Clindamycin phosphate 1.2%/benzoyl peroxide 3% fixed‐dose combination gel versus topical combination therapy of adapalene 0.1% gel and clindamycin phosphate 1.2% gel in the treatment of acne vulgaris in Japanese patients: A multicenter,randomized, investigator‐blind,parallel‐group study

Adapalene 0.1% (ADA) with clindamycin phosphate 1.2% (CLNP; ADA + CLNP) and the fixed‐dose combination containing CLNP and benzoyl peroxide 3% (CLNP/BPO 3%) are strongly recommended for the early treatment of acne vulgaris in Japan. Here, we compare the early efficacy and safety of CLNP/BPO 3% with Japanese standard topical use of ADA + CLNP in the treatment of acne vulgaris. In this phase IV, multicenter study, 351 patients were randomized to receive CLNP/BPO 3% or ADA + CLNP for 12 weeks. The primary end‐point was percentage change from baseline in total lesion (TL) counts at week 2. Secondary end‐points included the percentage change from baseline in TL, inflammatory and non‐inflammatory lesion (IL and non‐IL) counts, Investigator's Static Global Assessment (ISGA), quality of life (QoL [Skindex‐16]) and patient preference. Local tolerability scores and adverse events were also recorded. CLNP/BPO 3% provided a significantly greater percentage reduction from baseline in TL compared with ADA + CLNP at week 2, and week 4. Compared with ADA + CLNP, CLNP/BPO 3% was superior at reducing IL (but not non‐IL) over weeks 2–12, was more effective at improving patient QoL and ISGA, and scored higher in patient‐preference assessments. Both treatments were well tolerated; adverse drug reactions occurred more frequently in patients receiving ADA + CLNP (37%) than in those receiving CLNP/BPO 3% (17%). In conclusion, CLNP/BPO 3% showed greater efficacy for the early treatment of acne vulgaris in Japan, with a more favorable safety profile compared with ADA + CLNP.     

Combination therapy with adapalene-benzoyl peroxide and oral lymecycline in the treatment of moderate to severe acne vulgaris: a multicentre, randomized, double-blind controlled study

Background Oral antibiotics in association with a topical retinoid with or without benzoyl peroxide (BPO) are the recommended first‐line option in the treatment of moderate to severe acne vulgaris. Objectives To evaluate the efficacy and safety of oral lymecycline 300 mg with adapalene 0·1%–BPO 2·5% (A/BPO) fixed‐dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne vulgaris. Methods A total of 378 subjects were randomized in a double‐blind, controlled trial to receive once‐daily lymecycline with either A/BPO or vehicle for 12 weeks. Evaluations included percentage changes from baseline in lesion counts, success rate (subjects ‘clear’ or ‘almost clear’), skin tolerability, adverse events and patients’ satisfaction. Results The median percentage reduction from baseline in total lesion counts at week 12 was significantly higher (P < 0·001) in the lymecycline with A/BPO group (?74·1%) than in the lymecycline with vehicle group (?56·8%). The success rate was significantly higher (47·6% vs. 33·7%, P = 0·002) in subjects treated with lymecycline and A/BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P < 0·001) with a rapid onset of action from week 2 for noninflammatory lesions (P < 0·001) and week 4 for inflammatory lesions (P = 0·005). The A/BPO and lymecycline combination was well tolerated. The proportion of satisfied and very satisfied subjects was similar in both groups, but the number in the A/BPO group who were ‘very satisfied’ was significantly greater (P = 0·031). Conclusion These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris.     

A 6-month maintenance therapy with adapalene-benzoyl peroxide gel prevents relapse and continuously improves efficacy among patients with severe acne vulgaris: results of a randomized controlled trial

Background Acne vulgaris is a chronic and frequently recurring disease. A fixed‐dose adapalene‐benzoyl peroxide (adapalene‐BPO) gel is an efficacious and safe acne treatment. Objectives To assess the long‐term effect of adapalene‐BPO on relapse prevention among patients with severe acne after successful initial treatments. Methods This is a multicentre, double‐blind, randomized and controlled study. In total, 243 subjects who had severe acne vulgaris and at least 50% global improvement after a previous 12‐week treatment were randomized into the present study to receive adapalene‐BPO gel or its vehicle once daily for 24 weeks. Results At week 24, compared with vehicle, adapalene‐BPO resulted in significantly higher lesion maintenance success rate (defined as having at least 50% improvement in lesion counts achieved in initial treatment) for all types of lesions (total lesions: 78·9% vs. 45·8%; inflammatory lesions: 78·0% vs. 48·3%; noninflammatory lesions: 78·0% vs. 43·3%; all P < 0·001). Significantly more subjects with adapalene‐BPO than with vehicle had the same or better Investigator’s Global Assessment score at week 24 than at baseline (70·7% vs. 34·2%; P < 0·001). The time when 25% of subjects relapsed was 175 days with adapalene‐BPO and 56 days with vehicle (17 weeks earlier; P < 0·0001). Adapalene‐BPO led to further decrease of lesion counts during the study and 45·7% of subjects were ‘clear’ or ‘almost clear’ at week 24. It was also safe and well tolerated in the study. Conclusions Adapalene‐BPO not only prevents the occurrence of relapse among patients with severe acne, but also continues to reduce disease symptoms during 6 months.     

Adapalene–benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients

Background  Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0·1% and benzoyl peroxide (BPO) 2·5% has recently been developed for the once-daily treatment of acne.
Objectives  To evaluate the efficacy and safety of adapalene 0·1%–BPO 2·5% fixed-dose combination gel (adapalene–BPO) relative to adapalene 0·1% monotherapy (adapalene), BPO 2·5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.
Methods  In total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene–BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.
Results  Adapalene–BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient.
Conclusions  Adapalene–BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies.     

Open‐label,randomized, multicenter,phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long‐term use in patients with acne vulgaris: A secondary publication

An open‐label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long‐term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non‐inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end‐point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non‐inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long‐term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long‐term treatment of patients with acne vulgaris.     

Twelve‐week,multicenter, placebo‐controlled,randomized, double‐blind,parallel‐group,comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication

A placebo‐controlled, randomized, double‐blind, parallel‐group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non‐inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end‐point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris.     

Comparison of pulsed dye laser versus combined pulsed dye laser and Nd:YAG laser in the treatment of inflammatory acne vulgaris

Background: Both pulsed dye laser and combined 585/1064-nm (sequential dual-wavelength PDL and Nd:YAG) laser improves inflammatory skin disorders including acne vulgaris. Objective: To compare the efficacy of 585-nm pulsed dye laser versus sequential dual-wavelength PDL and Nd:YAG in treatment of acne vulgaris. Patients and method: Thirty patients with acne vulgaris were treated by PDL alone on half of the face while contra lateral half was treated by combined 585/1064 nm laser. Results: The study showed that inflammatory acne lesions count was significantly reduced by 82.5% (p 0.0001) on PDL sides and by 83.5% (p 0.00001) on combined 585/1064-nm side after 8 weeks, while reduction of non-inflammatory acne lesions was observed at 8 weeks by 58.4% and 71.5% respectively. However, difference between the two modalities was not statistically significant. Conclusion: PDL and combined PDL/Nd:YAG laser treatment were found to be an effective, safe and well-tolerated treatment option for inflammatory and non-inflammatory acne vulgaris.     

Randomized,controlled trial split‐faced study of 595‐nm pulsed dye laser in the treatment of acne vulgaris and acne erythema in adolescents and early adulthood

The high prevalence of acne vulgaris in teenagers has increased comorbidities. Lasers offer alternative options for acne treatment because they have rapid action, low systemic adverse effects, and do not require everyday treatment. To study the efficacy and patients’ satisfaction of 595‐nm pulse dye laser (PDL) treatment of acne vulgaris and acne erythema in adolescents and early adulthood, we designed a blocked‐randomized, split‐faced 595‐nm PDL (fluence 8 J/cm³ pulse duration 10 ms, spot size 7 mm, 2 session every 2 weeks) study in patients with mild to moderate acne by comparing the laser‐treated and non‐treated side. The acne lesion counts, acne erythema grading, and acne severity grading were evaluated at baseline and 2, 4, and 8 weeks. Thirty patients were recruited. The results showed no statistically significant difference except the papule count at week 4 which was ?1.828 on the treated side and 0.103 on the non‐treated side of the face, P‐value 0.0018. There was no statistically significant difference of acne severity grading and acne erythema grading between both sides of the face. The mean scores of patients’ satisfaction on the laser‐treated side were 75, 81, and 81%, respectively. The PDL treatment in this study reveals no significant improvement in acne therapy; however, the patients were satisfied with this laser treatment.     

Side‐by‐side comparison of photodynamic therapy and pulsed‐dye laser treatment of port‐wine stain birthmarks

Background Pulsed‐dye laser (PDL)‐mediated photothermolysis is the current standard treatment for port‐wine stain (PWS) birthmarks. Vascular‐targeted photodynamic therapy (PDT) might be an alternative for the treatment of PWS. Objectives To compare clinical outcomes of PDT and PDL treatment of PWS. Methods Two adjacent flat areas of PWS lesions were selected from each of 15 patients (two male and 13 female; age 11–36 years) and randomly assigned to either single‐session PDL or PDT. PDL was delivered using a 585‐nm pulsed laser. PDT was carried out with a combination of haematoporphyrin monomethyl ether (HMME) and a low‐power copper vapour laser (510·6 and 578·2 nm). Clinical outcomes were evaluated colorimetrically and visually during follow‐up. Results A total of nine red PWS lesions and six purple PWS lesions were treated. For red PWS, colorimetric assessment showed that the blanching rates of PDL and PDT at 2 months ranged from ?11% to 24% and 22% to 55%, respectively. For purple PWS, blanching rates of PDL and PDT ranged from 8% to 33% and 30% to 45%, respectively. Overall, there was a significant difference between the blanching effect of single‐session PDL treatment and a single‐session PDT treatment. Conclusions This side‐by‐side comparison demonstrates that PDT is at least as effective as PDL and, in some cases, superior. The true value of PDT for the treatment of PWS deserves further investigation.     

15 % Azelainsäuregel in der Behandlung der Akne. Zwei doppelblinde klinische Vergleichsstudien

Background: Topical measures are still the mainstay in the therapy of mild‐to‐moderate acne vulgaris. Azelaic acid 20 % in a cream formulation has been established as an efficacious and safe topical drug for 15 years. A new non‐alcoholic hydrogel formulation containing 15 % azelaic acid was clinically tested against two standard drugs – 5 % benzoyl peroxide (BPO) and 1 % clindamycin. Patients and Methods: In two independent, randomized, blinded comparative trials 15 % azelaic acid gel was clinically tested against 5 % benzoyl peroxide (BPO) gel in 351 patients and against 1 % clindamycin gel in 229 patients. The drugs were applied b. i. d. for 4 months. Results: Azelaic acid 15 % gel proved to be as effective as BPO and clindamycin with median % reduction of the inflamed lesion (papules and pustules) of 70 %, and 71 % respectively. The azelaic acid gel was well‐tolerated, the side effects (local burning and irritation) were distinctly less than with BPO but more pronounced than with clindamycin. Despite these side effects, the treatment was well‐accepted by the majority of patients. Conclusions: Azelaic acid gel is an effective topical monotherapy for mild‐to‐moderate acne vulgaris; its new gel form is an enrichment of acne therapy.     

Willingness-to-pay and quality of life in patients with vitiligo

Background Vitiligo is a chronic pigmentary disorder of the skin, affecting 1–2% of the general population. Although not life threatening, vitiligo may considerably influence patients’ health‐related quality of life (QoL) and psychological well‐being. Willingness‐to‐pay (WTP) is a construct reflecting disease burden and QoL reduction which has not yet been used in vitiligo. Objectives To assess the WTP and the QoL of patients with vitiligo. Methods Patients with vitiligo were included in a nationwide German postal survey. WTP was assessed by two standardized items, and QoL was evaluated using the Dermatology Life Quality Index (DLQI) and the EuroQol (EQ‐5D) questionnaire. QoL data were compared with n = 1511 patients from a national survey on psoriasis. Results The questionnaire was completed by 1023 patients (71·5% women, mean age 44·4 years, mean disease duration 20·3 years) with vitiligo. The mean DLQI was 7·0 (7·5 in women, 5·5 in men) compared with 8·6 in psoriasis. Of the patients with vitiligo, 24·6% had a DLQI > 10 which indicates severe QoL reductions, compared with 34·1% in patients with psoriasis. The highest mean DLQI value was observed in the patient group aged 20–29 years. EQ‐5D mean score was 83·6 compared with 75·3 in psoriasis. Of the patients with vitiligo, 32·9% would pay more than 5000 Euro in order to achieve complete disease remission. WTP was highest among middle‐aged patients (30–60 years). There was a significant correlation between DLQI scores and WTP (χ² = 65·43, P < 0·001). Moreover, WTP significantly correlated with duration of disease, and with body surface area affected (P < 0·001). Conclusions Vitiligo causes substantial disease burden as reflected by QoL impairment and high WTP, especially in women. These results should draw the attention of physicians to this disease, as appropriate education and treatment are likely to improve the QoL of patients with vitiligo and may support patients’ compliance and empowerment.     

A randomized, single-blind comparison of topical clindamycin + benzoyl peroxide (Duac®) and erythromycin + zinc acetate (Zineryt®) in the treatment of mild to moderate facial acne vulgaris

BACKGROUND: Antibiotics are often combined with other agents to provide topical acne treatments that are effective against both inflammatory and non-inflammatory lesions and minimize the development of antibiotic resistance. OBJECTIVES: To compare the clinical effectiveness of two combination treatments for facial acne: a ready mixed, once daily gel containing clindamycin phosphate (1%) plus benzoyl peroxide (5%) (CDP + BPO) and a twice daily solution of erythromycin (4%) plus zinc acetate (1.2%) (ERY + Zn). METHODS/PATIENTS: In this assessor-blind, randomized study, 73 patients were treated with CDP + BPO once daily and 75 patients with ERY + Zn twice daily. The treatment period was 12 weeks and lesion counts and global improvement were assessed at weeks 1, 2, 4, 8 and 12. RESULTS: CDP + BPO showed an earlier onset of action with a faster significant reduction in total lesion counts than ERY + Zn. The proportion of patients with at least a 30% improvement in non-inflammatory lesions at week 1 was 31.5% for CDP + BPO and 17.3% for ERY + Zn; the corresponding percentages for inflammatory lesions were 39.7% and 29.3%. A difference was also observed at week 2 (53.4% vs. 36.0% for non-inflammatory lesions and 72.6% vs. 53.3% for inflammatory lesions). The trend in favour of CDP + BPO, although less marked, continued to the end of the study, with reductions in the total lesion count at endpoint of 69.8% for CDP + BPO group and 64.5% for ERY + Zn group. Both treatments were well tolerated. CONCLUSIONS: CDP + BPO and ERY + Zn are effective treatments for acne but CDP + BPO has an earlier onset of action that should improve patient compliance.     

Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in Japanese patients? A multicenter,randomized, double‐blind,vehicle‐controlled,parallel‐group study

Benzoyl peroxide (BPO) as an anti‐acne medication is not yet approved in Japan. This study evaluated the efficacy and safety of a once‐daily topical application of BPO 3% gel versus an inert vehicle gel in Japanese acne patients. Three hundred and sixty patients were randomized to receive BPO 3% or vehicle for 12 weeks. The primary efficacy end‐point was absolute change in number of total lesions (TL) from baseline to week 12 to demonstrate the superiority of BPO 3% versus vehicle. Secondary efficacy end‐points were absolute and percent change in TL, inflammatory lesions (IL), non‐inflammatory lesions (non‐IL) and Investigator's Static Global Assessment (ISGA). Change in TL counts from baseline to week 12 for BPO 3% was superior to vehicle (difference, ?21.0; P < 0.001). Absolute and percent reductions in TL, IL and non‐IL counts were greater for BPO 3% at all study visits. The proportion of patients with improvement in ISGA scores was significantly higher with BPO 3% than with vehicle from week 2. All adverse events were mild or moderate. Adverse drug‐related reactions were higher for BPO 3% (30%) than with vehicle (5%). Local tolerability scores of grade 1 or more (slight to moderate) were more frequent with BPO 3% than vehicle with the most significant differences observed in dryness (56% vs 27% at week 1–4), peeling (19% vs 9% at week 1–2) and burning/stinging (58% vs 15% at week 1–12). These results indicate that BPO 3% is effective while maintaining a favorable safety and tolerability profile in Japanese acne patients.     

Prospective, open-label, comparative study of clindamycin 1%/benzoyl peroxide 5% gel with adapalene 0.1% gel in Asian acne patients: efficacy and tolerability

Background  Used as individual agents, topical antibiotics and benzoyl peroxide are known to be effective in treatment of acne. Clindamycin phosphate 1% with benzoyl peroxide 5% (CDP/BPO) is a new combination gel, made by rationale, in that combination drug is more effective than either ingredients used alone. Adapalene 0.1% (ADA) is the third-generation retinoid, shown to be as effective as other topical retinoid with well tolerability.
Objectives  To compare the efficacy and tolerability in combination of CDP/BPO in comparison with ADA in Asian patients with mild to moderate acne vulgaris.
Methods  Total of 69 patients, including 31 patients for CDP/BPO group and 38 for ADA group, with mild to moderate acne vulgaris were enrolled for a 12-week prospective, randomized, open-label comparative study of topical agents. Efficacy was assessed by lesion counts, acne grading system, and global improvement. Adverse events were also evaluated in scale of 0 (none) to 3 (severe).
Results  Both CDP/BPO and ADA were effective in reducing lesion counts and acne severity scale and showed significant global improvement. However, CDP/BPO offered greater efficacy against inflammatory lesions than ADA. Both drugs were well tolerated with minimal adverse drug reactions.
Conclusion  Combination formulation of CDP/BPO and ADA were shown to be both effective in decreasing total, inflammatory, and non-inflammatory lesion counts along with well tolerability in Asian patients with mild to moderate acne vulgaris.

Conflicts of interest

None declared     

Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial

Background Psoriasis is a chronic disease that significantly diminishes the health‐related quality of life (HRQOL). Infliximab is a chimeric, tumour necrosis factor α monoclonal antibody that has been shown to improve the signs and symptoms of plaque psoriasis. Objectives The objective of this study was to evaluate the effect of infliximab induction therapy on the HRQOL of patients with severe plaque psoriasis. Methods In this double‐blind, placebo‐controlled trial, 249 patients were randomly assigned to receive intravenous infusions of 3 or 5 mg kg^?1 of infliximab or placebo and were treated at weeks 0, 2 and 6. Patients completed the Dermatology Life Quality Index (DLQI) at baseline and week 10. Results Infliximab induction therapy resulted in a substantial improvement in HRQOL. At week 10, patients in the infliximab 3‐ and 5‐mg kg^?1 groups showed a median percentage improvement in DLQI scores of 84·0% and 91·0%, respectively, compared with 0% in the placebo group (P < 0·001). The median decrease from baseline in DLQI score at week 10 was 8·0 and 10·0 for the 3 and 5 mg kg^?1 infliximab groups, respectively, compared with 0 in the placebo group (P < 0·001). Thirty‐three per cent and 40% of patients in the 3 and 5 mg kg^?1 infliximab groups, respectively, had a DLQI score of 0 at week 10, compared with 2% in the placebo group (P < 0·001). There was a strong correlation between the percentage change from baseline at week 10 in Psoriasis Area and Severity Index (PASI) scores and the percentage change in DLQI scores during the same period (Spearman's correlation, 0·61, P < 0·001). When the infliximab and placebo treatment groups were combined, patients with at least 75% improvement in PASI scores between baseline and week 10 had a greater mean improvement in DLQI scores (81%) than those with 50–75% improvement in PASI during the same period (60%). Conclusions Infliximab induction therapy resulted in significant improvement in HRQOL in patients with severe psoriasis.     

Deutliche Einschränkung der Lebensqualität bei Patienten mit Pemphigus vulgaris: Ergebnisse der deutschen Bullous Skin Disease (BSD)‐Studiengruppe

Background: Pemphigus vulgaris is a potentially life‐threatening autoimmune disorder of the skin and mucous membranes characterized by antibodies against epidermal adhesion molecules. Clinically characteristic are painful chronic blisters or erosions of mucous membranes and skin. There are no published studies on the impact o this disease on quality of life. Patients and methods: This registration was performed within the scope of the German BSD (Bullous Skin Disease) study group, from November 1997 until January 2002. A total of 36 patients with the first diagnosis of pemphigus vulgaris were registered at the university hospitals of Dresden, Erlangen, Kiel, Mannheim, München and Würzburg. Thirty of the 36 (83 %) patients participated in the quality of life questionnaire utilizing the German version of ‘Dermatology Life Quality Index’ (DLQI) provided by A. Y. Finlay. The DLQI varies from 0 to 30 with an increased DLQI score indicating a decrease in quality of quality. Results: The overall DLQI total score of 10 ± 6,7 in the investigated pemphigus patients was significantly increased in comparison to other skin diseases. Conclusions: These results suggest that the DLQI can be a very useful additional outcome criteria for clinical studies with pemphigus vulgaris and in the treatment of these patients.     

Short- and medium-term efficacy of specific hydrotherapy in inherited ichthyosis

Background Management of inherited ichthyoses is symptomatic. Despite treatment, skin symptoms have a major impact on patients’ quality of life (QoL). Objectives To assess the short‐ and medium‐term efficacy of hydrotherapy on QoL and clinical symptoms of patients with inherited ichthyosis. Methods In this 9‐month prospective, open‐label, multicentre study, 20 children and 24 adults with ichthyosis were enrolled in several French reference and competence centres, 2 months before undergoing a 3‐week treatment with specific hydrotherapeutic management at Avène Hydrotherapy Centre. At baseline (2 months before hydrotherapy), beginning (D0) and end of hydrotherapy (D18), and 3 and 6 months later at the reference and competence centres, patients self‐assessed QoL using the Dermatology Life Quality Index (DLQI) or its paediatric version (Children’s DLQI), and investigators evaluated ichthyosis severity using a specific clinical ichthyosis score. Results The DLQI scores were significantly improved not only at the end of the hydrotherapy treatment (?56% vs. baseline; mean ± SD 3·59 ± 4·30 at D18 vs. 8·35 ± 5·71 at D0; P < 0·0001), but also at 3 months (?28% vs. baseline; P = 0·01) and 6 months after hydrotherapy (?26% vs. baseline; mean ± SD 5·21 ± 5·11 vs. 6·89 ± 5·38; P = 0·03) (primary criterion). Clinical symptoms were also significantly improved at all post‐treatment visits, with a decrease of the mean clinical ichthyosis score by ?38% between D0 and D18, by ?30% at 3 months and by ?31% at 6 months vs. baseline. Conclusions A 3‐week treatment at Avène Hydrotherapy Centre provided significant and persisting improvement of QoL and clinical symptoms in patients with inherited ichthyoses.     

Cortexolone 17α-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0·05% cream

Background Acne vulgaris is a disorder of the pilosebaceous unit in which the androgens contribute to its onset and persistence. The use of antiandrogens is therefore potentially effective; however, antiandrogens for topical use are not available on the market. Cortexolone 17α‐propionate (CB‐03‐01; Cosmo S.p.A, Lainate, Italy) is a new potent topical antiandrogen potentially useful in acne vulgaris. Objectives To evaluate the safety and the topical efficacy of CB‐03‐01 1% cream in acne vulgaris as compared with placebo and with tretinoin 0·05% cream (Retin‐A^®; Janssen‐Cilag). Methods Seventy‐seven men with facial acne scored 2–3 according to Investigator’s Global Assessment (IGA) were randomized to receive placebo cream (n = 15), or CB‐03‐01 1% cream (n = 30), or tretinoin 0·05% cream (n = 32) once a day at bedtime for 8 weeks. Clinical efficacy was evaluated every 2 weeks including total lesion count (TLC), inflammatory lesion count (ILC), acne severity index (ASI) and IGA. Safety assessment included local irritancy score, laboratory tests, physical examination, vital signs and recording of adverse events. Results CB‐03‐01 1% cream was very well tolerated, and was significantly better than placebo regarding TLC (P = 0·0017), ILC (P = 0·0134) and ASI (P = 0·0090), and also clinically more effective than comparator. The product also induced a faster attainment of 50% improvement in all the above parameters. Conclusions This pilot study supports the rationale for the use of topical antiandrogens in the treatment of acne vulgaris. CB‐03‐01 1% cream seems to fit with the profile of an ideal antiandrogen for topical use.     

Patient–physician consensus on quality of life in dermatology

This study was undertaken in order to establish the correlation between physician-assessed and patient self-reported quality of life (QOL) when using a proposed Dermatology Life Quality Index (DLQI) in a random Sample of 51 dermatological out-patients and in-patients. A substantial correlation was found between physician scores and DLQI (r²= 0·306, P < 0·001), suggesting that the DLQI can be used to assess QOL and general morbidity. Comparison of the observed and ideal patient–physician consensus suggests that patients with relatively benign or quiescent disease may overestimate disease impact, while dermatological patients with more malign or aggressive disease may underestimate it compared with the physician estimate.     

Prospective,open‐label,rater‐blinded and self‐controlled pilot study of the treatment of proliferating superficial infantile hemangiomas with 0.5% topical timolol cream versus 595‐nm pulsed dye laser

Topical timolol and 595‐nm pulsed dye laser (PDL) are both widely used in the treatment of superficial infantile hemangiomas (IH). However, to date, there is no reliable study comparing the therapeutic outcomes between the two treatment options. We designed the present study to evaluate and compare the efficacy and safety of timolol cream and PDL in the treatment of superficial proliferating IH. Twenty‐one patients with superficial IH were included in the study. Each lesion was divided into two regions; one part was treated with 0.5% topical timolol cream four times daily, and the other part was treated monthly with PDL. Both treatments were continued for 2–6 months. Five independent and blinded assessors were asked to judge the results in both the topical timolol‐treated and PDL‐treated parts by comparing photographs taken before and after treatment. Both treatments resulted in significant clinical improvements after 3.39 sessions in the 2‐month follow up. The average visual evaluation showed that PDL had significantly better results than topical timolol (6.55 ± 2.26 to 4.98 ± 2.92, P < 0.01). No patients experienced permanent side‐effects during the treatment. Our short‐term study revealed that PDL had better results compared with topical timolol cream application in the treatment of superficial proliferating IH. Further studies with longer follow‐up time and larger sample size are required to validate our findings.