Treatment of acne vulgaris with the retinoic acid derivative Ro 11-1430. A controlled clinical trial against retinoic acid.

In a double-blind, randomized, group-comparative clinical trial, 31 patients with acne vulgaris received topical treatment for 6-8 weeks with a lotion containing either 0.05% retinoic acid or 0.1% of the retinoic acid derivative Ro 11-1430. The side-effects erythema, desquamation and burning were significantly less frequent with Ro 11-1430 than with retinoic acid. The treatments appeared to be approximately equally effective in reducing the number of acne elements, but due to the limited number of patients studied, the trial was admittedly not sufficient to detect differences with regard to therapeutic efficacy.     

The retinoic acid derivative Ro 11-1430 (Tasmaderm) in patients with acne vulgaris not tolerating retinoic acid. A controlled multicenter trial against placebo.

In a double-blind randomized comparative multicenter trial, consisting of 29 patients with acne vulgaris who were unable to tolerate daily applications of retinoic acid, the retinoic acid derivative Ro 11--1430 (0.1% vanishing cream) was compared in a 6--8 weeks topical treatment with vanishing cream alone (placebo). Regarding efficacy, for most criteria measured the response was always better with Ro 11--1430 than with placebo, although the differences were not always statistically significant for several reasons, one probably being the small number of patients in the trial. Regarding tolerance, both treatments were satisfactory. Ro 11---1430 and placebo did not differ significantly regarding frequency and severity of erythema, desquamation and burning. These results suggest that treatment with Ro 11--1430 should be considered in acne patients who are unable to use retinoic acid due to severe local reactions.     

Ro 11-1430, a new retinoic acid derivative for the topical treatment of acne

The clinical efficacy and tolerance of a new retinoic acid derivative, Ro 11-1430, in the treatment of acne vulgaris have been compared with those of tretinoin in a double-blind trial with 60 patients during 8 weeks. The efficacy of both drugs was good. Tretinoin showed a tendency to give better effect but this was not statistically significant. However, tolerance of the new derivative was better. 48 of the patients were treated with Ro 11-1430 for another 3 months with good effect and tolerance. In a long-term study, 32 patients with previous irritation of tretinoin have been treated with Ro 11-1430 between 1.5 and 17 months with good tolerance.     

Systemic treatment of psoriasis with an oral retinoic acid derivative (Ro 10-9359)

Ninety-seven patients with severe psoriasis took part in a 1-year study to evaluate the effect of a new oral synthetic retinoid (Ro 10-9359). The trial was performed in a double-blind cross-over fashion. The treatment started with either 100 mg daily of Ro 10-9359 or placebo and the maintenance dose was in most cases 50 mg. Follow-up examinations were performed monthly and the parameters erythema, desquamation, infiltration and extent of the lesions were followed. Throughout the study there was a significant to highly significant preference for Ro 10-9359 shown by all parameters. More patients were in complete remission after Ro 10-9359 periods than after placebo periods. The side-effects of Ro 10-9359 on uninvolved skin and mucous membranes seemed to be largely dose-dependent. Twenty-three patients interrupted the study, four of them because of side-effects, mainly alopecia. Laboratory examinations revealed no aberrations which could be attributed to the therapy. One patient developed hepatitis during a placebo period.     

异维A酸软膏治疗寻常痤疮的多中心随机对照研究

目的评价异维A酸软膏治疗寻常痤疮的疗效和安全性。方法人组寻常痤疮患者240例,分别应用0．05%异维A酸软膏或0．05%维A酸乳膏,每晚1次,疗程8周。通过炎性皮损和非炎性皮损计数观察疗效,评价红斑、脱屑、烧灼感等局部不良反应。结果治疗8周,试验组皮损总数目从45．52±19．80减少至16．24±16．10,对照组皮损总数目从44．00±19．13减少至12．24±11．34,试验组有效率为69．75%,对照组有效率为80．51%,差异无统计学意义(P＞0．05),两组局部不良反应发生率差异无统计学意义(P＞0．05)。结论异维A酸软膏治疗寻常痤疮安全有效,其临床疗效及皮肤耐受性同0．05%维A酸乳膏相似。     

Open, controlled multicenter trial of 2 benzoyl peroxide preparations in the treatment of acne vulgaris

In an open multicenter study, 109 patients with acne vulgaris were treated with Cordes Benzoyl Peroxide (BPO) 3%, 5%, and 10%, or a reference preparation. With few exceptions, both preparations resulted in a good therapeutic outcome. Cordes BPO 5% and 10% were significantly better tolerated than the reference preparation. The efficacy of topical treatment with benzoyl peroxide depends largely on the patient's acceptance of this preparation; good tolerance leads to good compliance.     

Calcipotriol in psoriasis vulgaris: a controlled trial comparing betamethasone dipropionate + salicylic acid

Patients with psoriasis were treated with calcipotriol ointment, 50 ng/g, or betamethasone dipropionate + salicylic acid, applied twice daily, for 6 weeks. At the end of the trial patients took no treatment for a 1-month follow-up period. Extension of the psoriatic lesion, using a seven-point semiquantitative scale (0, no lesion; 1, lesions involving less than 10% of the body surface; 2, 10%–30%; 3, 30%–50%; 4, 50%–70%; 5, 70%-90%; 6, 90%–100%), and severity of the erythema, infiltration, and exfoliation, using a four-point scale (0, no skin involvement; 3, maximal), were assessed at baseline and at the fortnightly check-ups. The scores were then employed to calculate a PASI score.¹ The dermatologist finally expressed his judgment on the efficacy of treatment, using a five-point scale (?1, worsening; 3, healing). Similarly, patients were asked to express an opinion on the acceptability of treatment, using a five-point scale (1, nil; 5, excellent). At baseline and at the second and sixth weeks of treatment, routine laboratory tests were carried out. Patients could decide to stop the trial for healing, adverse reactions, or failure. Failure was defined as no change or worsening of baseline conditions. All patients gave their witnessed consent to take part in the trial, which was conducted following the conditions set down in the Declaration of Helsinki. Statistical analysis was carried out using Student's t-test for independent data to check initial homogeneity and, when appropriate, using the ratings of efficacy, Mest for paired data, Friedman's test, and the chi-squared test. Patients were eligible if they were over 18 years of age, of either sex, with mild, stable psoriasis, and had not used topical for this disease in the 2 weeks prior to the trial or systemic therapies in the 2 months prior to the trial. Patients with psoriasis affecting only the face, scalp, and genitals were not admitted. Also excluded were pregnant or breast-feeding women, and patients requiring vitamin D-based therapies (>400 lU/day) or systemic steroids. Patients with hepatic or renal failure were not eligible. A total of 160 patients were enrolled (109 men, 51 women), with a mean age 49.9 ± 14.2 (standard cjeviation) years. Eighty patients (mean age 50.1 ± 14.7 years) were randomly assigned to treatment with calcipotriol (C), and 80 (mean age 49.7 ± 13.8 years) to betamethasone dipropionate + salicylic acid (BD+AS); the two groups were homogeneous. In the group with C, 20 patients stopped treatment before the completion of the trial, and in the group with BD+AS 17 stopped treatment. Ten patients treated with C and seven with BD+AS were healed early; respectively one and three cases were classified as failures, and three and five were lost to follow-up. There were six cases of discontinuation because of intolerance or adverse reactions to C, and two because of intolerance or adverse reactions to BD+AS. By the end of the trial therapy lesions on the trunk had completely disappeared in 17 patients (21,3%) treated with C and In 13 (16.3%) given BD+AS. Lesions on the arms disappeared in 17 (21.3%) and 12 (15,0%) patients respectively, and on the legs in 11 (13.8%) and eight (10,0%). These reductions were significantly different from baseline (P < 0.05, chi-squared test), although the differences between treatments were not significant for each area. Erythema of the trunk disappeared in 17 patients (21.3%) treated with C and in 14 (17.5%) given BD+AS. Reductions on the arms were recorded in 20 (25.0%) and 18 (16.3%) patients respectiveiy. Neither drug had much effect on erythema of the iegs; which did, however, finaiiy regress compieteiy in 16 patients (20.0%) given C and in 10 (12.5%) given BD+AS. Skin infiitration on the trunk disappeared totaliy in 24 patients (30%) with both treatments; it disappeared on the arms of 44 patients (55.0%) given C and 45 (56.2%) of those given BD+AS; infiitration disappeared on the legs in 34 (42.5%) and 29 (36.3%) patients respectiveiy. Exfoliation on the trunk disappeared in 39 patients (48.8%) given C and in 33 (41.3%) of those given BD+AS; scales on the arms were healed in 49 and 44 patients (61.3% and 55.0%), respectively, and on the iegs in 19 and 30 (23.8% and 37.5%). At the end of the study the reductions in the scores of erythema, infiltration, and exfoiiation from baseline were significant (P < 0.01, Friedman), but not between treatments (NS, chi-squared test). By 6 weeks of treatment, PASI scores had dropped 66.8% and 60.8% respectively (P < 0.001 from baseline. Student's f-test for paired data, Fig. 1). Investigating dermatologists assessed 79% of patients in the group with C as ‘improved’ or ‘healed’, and 89.4% of patients with BD+AS. Acceptability was assessed as ‘good’ or ‘excellent’ by 83.8% of the patients treated with C, and by 76.3% of those given BD+AS. Of the 80 patients treated with C, 66 turned up for the visit 1 month after stopping treatment; and of the 80 given betamethasone, 64 turned up. in many cases improvement continued to the point of lesions disappearing in all the areas treated with both drugs, and somewhat more so in areas treated with C. Erythema, the symptom that took longest to show an improvement, disappeared in many cases (Fig. 2). No significant changes were found in the main laboratory variabies. Seven patients in the group treated with C complained of 11 local adverse reactions; burning sensation (2.5%), itching at ths site of application (3.8%), edema (1.2%), folliculitis (1.2%), erythema (3.8%), and dry skin (1.2%). In four cases treatment was stopped, and two of these were given a topical steroid and vaseline as replacement therapy. No adverse reactions were reported in the group treated with BD+AS.     

Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris

This is a clinical, prospective, and longitudinal study comparing the efficacy and incidence of averse effects of topical isotretinoin against those of topical retinoic acid in the treatment of acne vulgaris. The 30 participants were recruited from the patients attending the outpatient clinic of the Department of Dermatology of “Dr Manuel Gea González” General Hospital in Mexico City. They belonged to either sex and any race, their ages ranged between 13 and 30 years, and they presented with 15 to 100 facial inflammatory lesions (papulo-pustules) and/or 15 to 100 noninflammatory lesions (comedones) and no more than three nodulo-cystic lesions. The criteria of exclusion were as follows: pregnancy or lactation, systemic treatment with steroids, antibiotics, antiandrogens, or oral retinoids in the preceding 24 months, treatment with ultraviolet radiation, hypersensitivity to retinoids, or a severe systemic illness. From 44 interviewed patients, 14 were excluded. A detailed clinical history was obtained from the remaining individuals, the degree of seborrhea was recorded, and acne lesions were counted. Each patient received either isotretinoin gel 0.05% or retinoic acid cream 0.05%. The patients were instructed to wash their faces in the mornings and evenings with a neutral soap, and to apply the product after the evening cleansing. The patients were examined again after 2, 4, 8, and 12 weeks of treatment and, at each appointment, the number of lesions was recorded and the severity of acne was graded according to the classification of Plewig and Kligman.¹ The seriousness of the adverse effects, such as stinging, pruritus, erythema, xerosis, and desquamation, was evaluated blindly by an investigator who did not know what group the patient belonged to, and graded as 1=mild, 2=moderate, and 3=severe. The efficacy of each drug was determined by the reduction in the number of lesions between weeks 0 and 12 of treatment. An excellent response corresponded to a 76%–100% reduction of the lesions, a good response to a 51%–75% reduction, a fair response to a 26%–50% reduction, and a poor response to a 0%–25% reduction. The results were analyzed statistically using the chi-square test, the exact test of Fisher and the test of Wilcoxon–Mann–Whitney. The changes in the numbers of lesions between weeks 0 and 12 were analyzed separately for each group of treatment, and the level of statistical significance was fixed at 0.05. The analysis was performed with the aid of a Stat program, version 4.0. Results The patients were assigned randomly to either Group I (isotretinoin) or Group II (retinoic acid). Each group was composed of 15 individuals and, as a coincidence, in each group there were nine women and six men. The clinical differences between the groups at the first visit were not statistically significant. In both groups, there was, in general, a good response to treatment (Fig. 1). Both drugs had a similar degree of efficacy on inflammatory lesions. At the first visit, grades III and IV predominated, whereas, after 12 weeks of treatment, most patients were classified in grades I or II (Fig. 2). Similar results were observed regarding noninflammatory lesions (Fig. 3). Ten of the patients of Group II complained of stinging associated with the treatment, especially at weeks 8 and 12, as well as erythema and desquamation at the 12th week. Erythema and stinging lasted for minutes or hours, whereas desquamation persisted for several days. Seven individuals receiving isotretinoin mentioned irritation, which was of a mild degree.     

Topical tretinoin (retinoic acid) improves melasma. A vehicle-controlled, clinical trial

Melasma is a common disorder of cutaneous hyperpigmentation predominantly affecting the faces of women. Little is known about the aetiology of melasma, and treatment is frequently disappointing. Topical tretinoin is of benefit in treating other forms of hyperpigmentation, for example liver spots, and we therefore investigated its effectiveness in melasma. Thirty-eight women completed a randomized, vehicle-controlled study, in which they applied 0.1 % tretinoin (n=19) or vehicle cream (n=19) once daily to the face for 40 weeks. At the end of treatment 13 (68%) of 19 tretinoin-treated patients were clinically rated as improved or much improved, compared with 1 (5%) of 19 in the vehicle group (P=0.0006). Significant improvement first occurred after 24 weeks of tretinoin treatment. Colorimetry (an objective measure of skin colour) demonstrated a 0.9 unit lightening of tretinoin-treated melasma and a 0.3 unit darkening with vehicle (P=0.01); these results correlated with clinical lightening (r=0.55, P=0.0005). Histologically, epidermal pigment was reduced 36% following tretinoin treatment, compared with a 50% increase with vehicle (P=0.002). Reduction in epidermal pigment also correlated with clinical lightening (r=0.41, P=0.01). Moderate cutaneous side-effects of erythema and desquamation occurred in 88% of tretinoin-treated and 29% of vehicle-treated patients. Topical 0.1% tretinoin produces significant clinical improvement of melasma, mainly due to reduction in epidermal pigment, but improvement is slow.     

他扎罗汀乳膏短时接触疗法治疗寻常痤疮的临床研究

目的 评价0.1%他扎罗汀乳膏短时接触疗法治疗寻常痤疮时能否有效减轻局部不良反应,以及对临床疗效和症状反复的影响。方法 多中心、随机对照方法,将纳入观察的187例寻常痤疮病例分为短时接触疗法8周组,短时接触疗法12周组和常规治疗组,按Doshi痤疮综合分级系统（GAGS）计分评价,观察在治疗开始前（基线期）、完成时以及完成后的第2、4、8周内症状变化情况,评估局部不良反应和疗效,以及对病情反复的影响。结果 短时接触疗法8周组、12周组和常规治疗组局部不良反应率分别为11.48%、12.90%和38.33%,三组比较,差异有统计学意义（χ2 = 13.31,P < 0.01）。短时接触疗法12周组总有效率（80.65%）较8周组（63.93%）高（χ2 = 3.84,P < 0.05）。三组总有效率比较,差异无统计学意义（χ2 = 1.98,P > 0.05）。短时接触疗法12周组能明显降低病情反复,三组间2、4、8周各随访段病情反复率比较,差异均有统计学意义（χ2 = 3.29,3.78和5.85,P < 0.05 或P < 0.01）。结论 0.1%他扎罗汀乳膏短时接触疗法治疗寻常痤疮能有效减轻局部不良反应,且不降低疗效;而延长短时接触疗法疗程能减少症状反复,提高疗效。     

他扎罗汀乳膏短时接触疗法治疗寻常痤疮的临床研究

目的 评价0.1%他扎罗汀乳膏短时接触疗法治疗寻常痤疮时能否有效减轻局部不良反应,以及对临床疗效和症状反复的影响.方法 多中心、随机对照方法,将纳入观察的187例寻常痤疮病例分为短时接触疗法8周组,短时接触疗法12周组和常规治疗组.按Doshi痤疮综合分级系统(GAGS)计分评价,观察在治疗开始前(基线期)、完成时以及完成后的第2、4、8周内症状变化情况,评估局部不良反应和疗效,以及对病情反复的影响.结果 短时接触疗法8周组、12周组和常规治疗组局部不良反应率分别为11.48%、12.90%和38.33%,三组比较,差异有统计学意义(X2=13.31,P<0.01).短时接触疗法12周组总有效率(80.65%)较8周组(63.93%)高(X2=3.84,P<0.05).三组总有效率比较,差异无统计学意义(X2=1.98,P>0.05).短时接触疗法12周组能明显降低病情反复,三组间2,4、8周各随访段病情反复率比较,差异均有统计学意义(X2=3.29,3.78和5.85,P<0.05或P<0.01).结论 0.1%他扎罗汀乳膏短时接触疗法治疗寻常痤疮能有效减轻局部不良反应,且不降低疗效;而延长短时接触疗法疗程能减少症状反复,提高疗效.     

The prevalence of common skin conditions in Australian school students: 3. Acne vulgaris

Although viral warts are common, their exact frequency in the community is often underestimated and not well recorded. A random sample of 2491 students from schools throughout the State of Victoria, Australia were examined by dermatologists and dermatology registrars to record the prevalence of common, plantar and plane warts. The overall prevalence of warts adjusted for the age and sex of Victorian school children was 22% (95% confidence interval (CI) 20.1–20.7) varying from 12% (95% CI 9.4–15.7) in 4–6 year olds to 24% (95% CI 18.3–30.4) in 16–18 year olds. Common warts were the most frequent (16%) compared with plantar warts (6%) and plane warts (2%). There was no difference in the overall frequency of warts between males and females and there was no difference in frequency between those who had eczema and those who did not. Almost 40% of those found to have warts on examination had indicated on the survey questionnaire that they did not have any of these lesions. Of those who knew that they had warts, only 38% had used any treatment for them. These data, the first community-based prevalence data on warts ever published from Australia, confirm that warts are indeed common. They suggest the need for education programmes in schools on the nature of these lesions and the treatment available.     

Fixed combination of tazarotene and betamethasone dipropionate for treatment of psoriasis vulgaris: The result of a phase 3, multicenter,randomized controlled trial

Long-term use of corticosteroids or local use of tazarotene (TAZ) alone for the treatment of psoriasis cause safety issues and low compliance rates. Combining these two may optimize their efficacy and minimize safety concerns. This study aimed to evaluate the clinical efficacy and safety of a fixed combination of TAZ 0.05% and betamethasone dipropionate 0.05% (BM) for psoriasis vulgaris. A multicenter, randomized, single-blinded, controlled phase 3 clinical trial was conducted. A total of 600 Chinese subjects with psoriasis vulgaris were randomized (3:1:1) to TAZ/BM cream, TAZ gel or BM cream groups for 6 weeks with an 8-week follow up. The primary efficacy assessment end-point was 75% improvement in Psoriasis Area and Severity Index (PASI-75) at 6 weeks. Secondary outcome assessments included PASI-90, percentage of PASI decrease and so forth. Safety and treatment-related adverse events were monitored throughout the study. Our results demonstrated that the TAZ/BM group exhibited statistically significant superiority in PASI-75 over TAZ (6.74% vs 1.67%) within 2 weeks. After 6 weeks of treatment, PASI-75 was 44.94% in the TAZ/BM group while 19.17% and 35.00% in the TAZ and BM group, respectively. At the 8-week follow up, the relapse rate of the TAZ/BM group was significantly lower than the BM group (10.62% vs 29.63%, P = 0.0269) though comparable with the TAZ group (10.00%). The most frequently reported treatment-related adverse event was mild to moderate level of skin irritation events. TAZ/BM combination has significant advantages over TAZ, including satisfying efficacy, rapid onset and reduced local stimulation. Meanwhile, compared with BM, it has the advantages of longer relief time and reduced clinical relapse rate. The TAZ/BM combination drug provides psoriatic patients an alternative drug with high efficacy and low relapse rate and safety concerns.     

Acne therapy with isotretinoin in dermatologic practice. A multicenter phase IV study of 788 patients

In a multicenter study, 788 patients suffering from severe acne resistant to therapy were treated with isotretinoin by 758 dermatologists in private practices. The study was conducted using standardized test forms and questionnaires. The goal of the study was to establish the risk/benefit ratio of the drug, if it was applied to patients of a dermatological practice. The initial daily dose amounted to 0.5 mg/kg body weight, the time of treatment was 12 to 16 weeks. The clinical efficacy was judged very good or good by 90% of the doctors and patients. The kind, frequency, and intensity of the side effects observed corresponded with those found in previous studies conducted at hospitals. Our critical analysis of the results left no doubt about the therapeutic value and the safety of isotretinoin, if it is used by dermatologists in private practices.