A double-blind study of 1% metronidazole cream versus systemic oxytetracycline therapy for rosacea

In a randomized double-blind trial fifty-one patients with rosacea were treated for 2 months with either 1% metronidazole cream and placebo tablets or with 250 mg oxytetracycline tablets taken twice daily, and placebo cream (the cream base). The patients were assessed before and at the end of the trial, using the following criteria: (1) overall clinical assessment, (2) lesion counts, (3) degree of erythema, (4) independent photographic evaluation, (5) patients' opinion. An improvement was shown in 90% of the patients of both groups, and there was no significant difference between the two treatments. One per cent metronidazole cream has been shown to be significantly better than a placebo cream in the treatment of rosacea (Gamborg Nielsen, 1983a), It was therefore considered important to compare the cream with conventional therapy, and for this reason a double-blind study of 1% metronidazole cream versus a daily dose of 500 mg oxytetracycline was performed.     

Treatment of rosacea with 1% metronidazole cream. A double-blind study

Eighty-one patients with rosacea were treated with either I% metronidazole cream or the cream base as a placebo for two months. The trial was performed double-blind, and the patients were assessed once each month. The variates studied were: (I) overall clinical assessment, (2) lesion counts, (3) degree of erythema, (4) independent photographic evaluation, and (5) patient's opinion. Four patients dropped out of the trial (one treated with metronidazole, three with placebo). In all the variates, I% metronidazole cream proved to be significantly more effective than placebo.     

Efficacy of bufexamac (NFN) cream in skin diseases. A double-blind multicentre trial.

The effect of a new non-steroid anti-inflammatory substance (bufexamac) in a special constituent was compared with that of 0.1% triamcinolone acetonide, 1% hydrocortisone cream, and placebo during a double-blind multicentre trial. The clinical effect of these four creams was studied in 193 patients receiving treatment for the following skin disorders: atopic dermatitis, allergic contact dermatitis, and non-allergic contact dermatitis, as well as dermatitis seborrheica. After 2 and 4 weeks' treatment, when 193 and 157 patients, respectively, were re-examined, the effect of triamcinolone acetonide and hydrocortisone cream was significantly better, than that obtained with bufexamac in the cream basis employed. On the other hand, no statistically significant difference in effect between bufexamac and placebo cream was observed.     

The use of a corticosteroid cream for immediate reduction in the clinical signs of acne vulgaris

A controlled trial of the anti-inflammatory effect of a steroid cream (clobetasol propionate) in 11 patients with moderate acne was assessed over a 3 week period. The placebo cream was the base of the steroid cream. Therapeutic effect was assessed by the number of active and less actively inflamed papules and pustules present at the beginning and end of the 3 week trial period. No significant change in lesion counts was observed. This result indicates that a potent topical steroid cream produces no short-term improvement in patients with moderate acne.     

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.     

A randomized, double-blinded, placebo-controlled trial of pseudocatalase cream and narrowband ultraviolet B in the treatment of vitiligo

Background  Pseudocatalase cream in conjunction with narrowband ultraviolet B (NB-UVB) has previously been reported to result in repigmentation of vitiliginous skin.
Objectives  The purpose of this 24-week, double-blind, placebo-controlled, randomized, single-centre trial was to assess the efficacy of pseudocatalase cream and NB-UVB vs. placebo and NB-UVB for the treatment of vitiligo.
Methods  Patients with active vitiligo on their face and/or hands applied either pseudocatalase cream or placebo to their whole body, twice daily for 24 weeks. NB-UVB therapy was administered three times a week for the duration of the trial. Efficacy was assessed primarily by digital image analysis of photographs.
Results  Thirty-two patients were randomized to either the pseudocatalase arm ( n  =   14) or placebo ( n  =   18). Between-group analysis did not show a statistically significant improvement in percentage area affected in the pseudocatalase cream group when compared with placebo. However, a statistically significant improvement was found within each group by week 12, which was maintained throughout the study.
Conclusions  NB-UVB treatment is a moderately effective treatment for vitiligo. Pseudocatalase cream does not appear to add any incremental benefit to NB-UVB alone.     

Topical 5-aminosalicylic acid: a treatment for aphthous ulcers

A double-blind placebo controlled trial of 5% 5-aminosalicylic acid (5-ASA) cream for the treatment of oral aphthous ulcers was carried out on 22 subjects. The cream or a placebo (11 patients each) was applied to the ulcers three times daily for up to 14 days. Daily discomfort was reduced by half (P less than 0.01) and less pain (P less than 0.05) was experienced by the treated group. Treatment with 5-ASA shortened healing time (7 vs. 11 days, P less than 0.01) and reduced the difficulty in eating (P less than 0.05). No significant side-effects were reported. We believe 5-ASA cream to be an effective treatment for aphthous ulcers.     

A phase III, randomized, double-blind, placebo-controlled study of peldesine (BCX-34) cream as topical therapy for cutaneous T-cell lymphoma

BACKGROUND: The purine nucleoside phosphorylase inhibitor peldesine is a new agent being evaluated as a T-cell inhibitor. OBJECTIVE: We attempted to determine the efficacy of peldesine (BCX-34) in a 1% dermal cream formulation as a treatment for cutaneous T-cell lymphoma (CTCL). METHODS: Ninety patients with patch and plaque phase CTCL, histologically confirmed by a referee dermatopathologist, were enrolled in a randomized, double-blind, placebo-controlled study. BCX-34 dermal cream 1% or the vehicle cream (as a placebo control) was applied twice daily to the entire skin surface for up to 24 weeks. Efficacy of the topical therapy was assessed in terms of complete or partial (> or = 50%) clearing of patches and plaques. RESULTS: Of the 89 patients able to be examined, 43 received BCX-34 and 46 received the placebo vehicle cream. One patient withdrew early and was not analyzed. The two groups were well balanced for potential prognostic factors. A total of 28% (12/43) of the patients treated with BCX-34 showed a response, but 24% (11/46) of patients who received vehicle also responded (P =.677). CONCLUSION: Although BCX-34 dermal cream 1% was not significantly better than the control as therapy for patch and plaque-phase CTCL, this appears to be the first published placebo-controlled trial evaluating treatment for CTCL. Whether the vehicle cream has more than a placebo therapeutic effect is unclear. The relatively high (24%) placebo response rate should be kept in mind in assessing other treatments for early-stage CTCL.     

Topical treatment of recurrent genital herpes simplex virus infections with trisodium phosphonoformate (foscarnet): double blind, placebo controlled, multicentre study.

A double blind, placebo controlled trial was performed in nine sexually transmitted diseases (STD) clinics in the United Kingdom and the Netherlands to investigate the efficacy of trisodium phosphonoformate (foscarnet) cream in treating recurrent genital herpes simplex virus (HSV) infection. The study group comprised 145 male and 85 female patients. Men received 0.3% foscarnet cream and women 1% foscarnet cream for five days. The difference in time to healing between patients receiving foscarnet or placebo was not significant. Fewer patients treated with foscarnet had positive viral cultures after treatment, but the difference was not significant. The development of new lesions, however, was significantly less common in patients given foscarnet. Though topical foscarnet is a safe drug, no appreciable efficacy in treating recurrent genital HSV infection could be shown.     

Single‐dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double‐blind randomized controlled trial

This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double‐blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re‐evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.     

Combined treatment of psoriasis with a new aromatic retinoid (Tigason) in low dosage orally and triamcinolone acetonide cream topically: a double-blind trial

In a multicentre double-blind trial the effect of three therapy regimens was studied for 6 weeks in ninety psoriasis patients: (1) aromatic retinoid (Ro 10-9359) orally (0.50-0.66 mg/kg body weight) and placebo cream topically; (2) aromatic retinoid (Ro 10-9359) (same dosage) with 0.1% triamcinolone acetonide and 5% salicylic acid in lanette wax cream; (3) placebo capsules with 0.1% triamcinolone acetonide and 5% salicylic acid in lanette wax cream. Regimen 1 had virtually no effect and regimen 2 gave better results than regimen 3 for almost ail parameters, although statistical significance was reached for only some of them. The 6 week double-blind period was followed by an open study in which all patients were treated according to regimen 2. The clinical result could be maintained up to the end of the study (18 weeks), when more than 60% of the patients showed good to excellent (80–100%) improvement. Most of the patients had dry lips, but generally without clinical symptoms of a cheilitis. The other well-known side-effects of retinoid were mild and relatively rare. It is concluded that the combination of the aromatic retinoid (Ro 10-9359) given in low dosage orally with corticosteroids topically is as effective as therapy with the retinoid in high dosage alone, but with markedly less side-effects.     

Double-blind comparison of 2% ketoconazole cream and placebo in the treatment of tinea versicolor

Malassezia furfur (Pityrosporum orbiculare) was confirmed by microscopic potassium hydroxide (KOH) examination in 101 patients with recurring lesions of tinea versicolor. In a double-blind comparative study, patients were randomly assigned to once-daily ketoconazole 2% or placebo cream. At the end of treatment, 98% (p less than 0.0001) of the patients using ketoconazole and 28% of those using placebo responded clinically (healed or had mild residual disease). There was an overall 84% mycologic cure rate (negative KOH at treatment end) for patients using ketoconazole 2% cream and 10% for those using placebo cream (p less than 0.0001). Ketoconazole-treated patients who were cured at the end of treatment remained cured 8 weeks later. By contrast 75% of those responding to placebo had relapsed by the 8-week follow-up visit. Follow-up after 2 years revealed that 79% (38/48) of the patients treated with ketoconazole remained clear 12 or more months.     

A comparison of acyclovir cream versus placebo cream versus liquid nitrogen in the treatment of viral plantar warts

52 patients with a clinical diagnosis of verruca plantaris were entered into a randomised study of acyclovir cream versus placebo cream versus liquid nitrogen. 47 completed the initial 8-week assessment period. At first, liquid nitrogen was used as a positive control but after the entry of 33 patients it was discontinued as an initial therapy in order to obtain maximal numbers of patients on the cream treatments. At the end of the 8-week assessment period 5 of 18 (placebo cream), 7 of 18 (acyclovir cream) and 1 of 11 (liquid nitrogen) patients were completely cleared of their plantar warts. Patients who failed to clear on cream or liquid nitrogen treatments after the initial assessment period but who wished to continue therapy were subsequently treated with liquid nitrogen. Of a total of 27 patients treated vigorously with liquid nitrogen, for periods of time ranging from 2 to 34 weeks, only 11 were completely cleared of their warts at the end of the study. It is concluded that liquid nitrogen should not be considered as a routine treatment for plantar warts and that acyclovir cream is no better than placebo in the treatment of this condition.     

Efficacy and tolerability of topical 1% cidofovir cream for the treatment of external anogenital warts in HIV-infected persons

BACKGROUND: Treatment options for anogenital warts in patients with HIV-1 are unsatisfactory because they fail to eradicate latent human papillomavirus. GOAL: To determine tolerability and efficacy of topical 1% cidofovir cream for the treatment of external anogenital warts in HIV-infected patients. STUDY DESIGN: A randomized, placebo-controlled, single-blind, crossover pilot study of either 1% cidofovir cream or placebo applied once daily 5 days a week for 2 weeks followed by 2 weeks of observation was performed. RESULTS: Six patients were randomized to 1% cidofovir cream and six to placebo. The latter patients eventually received 1% cidofovir cream. Thus, 12 treatment rounds of cidofovir were compared with six rounds of placebo. A reduction of more than 50% in the total wart area achieved by seven cidofovir treatments (58%), as compared with no placebo regimen (P = 0.02). Local reactions occurred in 10 of the 12 patients treated with cidofovir, as compared with 0 of the 6 subjects in the placebo group (P < 0.001). CONCLUSIONS: For the initial clearance of anogenital warts in HIV-infected patients, 1% cidofovir cream is significantly more effective than vehicle cream. Local mucosal erosion is a common side effect.     

胶原贴敷料联合丁酸氢化可的松乳膏治疗面部过敏性皮肤病65例临床观察

目的观察胶原贴敷料联合丁酸氢化可的松乳膏治疗面部过敏性皮肤病的疗效。方法观察组和对照组均口服盐酸左西替利嗪片5mg,1次/d,同时外用丁酸氢化可的松乳膏,2次/d,连用10天;此外观察组每天用胶原贴敷料敷面1次,连用10天,比较两组患者的疗效。结果观察组治愈率为68.33%,有效率为80.00%;对照组分别为38.33%和53.33%,两组治愈率与有效率比较,差异均有统计学意义(P均<0.05)。结论胶原贴敷料作为面部过敏性皮肤病的辅助疗法,效果明确,值得临床应用。     

Management of Female Genital Warts with an Analog of Imiquimod 2% in Cream: A Randomized,Double-Blind,Placebo-Controlled Study

The purpose of this randomized, double-blind, placebo-controlled study was to determine the clinical efficacy and tolerability of an analog of imiquimod (2%) in cream to cure genital warts in women. Sixty preselected women, ranging between 18 and 45 years of age (mean 24.3) and having 411 lesions (mean 6.8) with clinical, histopathological and polymerase chain reaction (PCR) confirmed diagnosis of human papilloma virus (HPV) infection were randomized to two parallel groups. Each patient received a precoded 40-g tube and instructions on how to apply the trial medication to their lesions at home two times daily for five consecutive days per week. The active treatment period was six weeks. Patients were evaluated on a weekly basis. A clinically and PCR established total clearance of target warts was recorded as a cure. By the end of the treatment, 43.3% of patients and 42.8% of warts were cured. Code disclosure revealed that imiquimod cream had cured 83.3% of the treated patients and 84.3% of the treated warts, while the placebo healed one subject and four warts (p<0.0001). Eight patients (13.3%) in the imiquimod group experienced mild to moderate, non-objective, drug-induced symptoms with no dropouts. Among the 26 cured patients, five had a relapse after 11 months. In conclusion, the data presented demonstrate that 2% imiquimod in cream with mild to moderate subjective side effects is significantly more effective than placebo in eliminating genital warts in women.     

Laser-assisted penetration of topical anesthetic in adults

OBJECTIVE: To determine whether pretreatment of skin with erbium:YAG (Er:YAG) laser-assisted delivery facilitates the penetration of lidocaine cream to provide anesthesia suitable for needlesticks after just 5 minutes. DESIGN: Trial 1 was a double-blind randomized controlled trial, whereas trial 2 was a nonblinded randomized controlled trial. SETTING: The study was conducted in 2 facilities, an academic and a private clinical research unit. PARTICIPANTS: A total of 320 healthy volunteers, aged 18 to 65 years and of any Fitzpatrick skin phototype. INTERVENTIONS: Trial 1 involved an Er:YAG laser pretreatment to disrupt the stratum corneum followed by an application of 4% lidocaine cream on one arm, and a laser pretreatment plus placebo on the other arm. Trial 2 involved an application of 4% lidocaine cream alone on one arm, and a laser pretreatment followed by an application of 4% lidocaine cream on the other arm. MAIN OUTCOME MEASURE: Self-reported pain perception on a 100-mm visual analog scale after quick insertion and removal of a 25-gauge hypodermic needle on the treatment sites. RESULTS: Data from the 2 trials showed that there was a 62% pain reduction with laser pretreatment plus lidocaine compared with laser pretreatment plus placebo, and a 61% pain reduction with laser pretreatment plus lidocaine, compared with lidocaine alone. The decrease in pain in both trials was statistically significant (P<.001). Adverse events reported 48 hours after treatment were few and mild. CONCLUSION: Treatment with the Er:YAG laser followed by lidocaine cream is a safe, effective, and efficient means of inducing skin anesthesia that significantly reduces the pain of hypodermic needle insertion.     

The treatment of bacterial vaginosis with a 3 day course of 2% clindamycin cream: results of a multicentre, double blind, placebo controlled trial. B V Investigators Group.

OBJECTIVE--To evaluate the efficacy and safety of a 3 day course of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis. DESIGN--A prospective, randomised, double-blind placebo controlled study. SETTING--Departments of genitourinary medicine at Birmingham, Nottingham, Liverpool, Swansea, Leeds, Walsall, Stoke Mandeville, Southampton, Plymouth, Bishop's Stortford and Glasgow. SUBJECTS--Pre-menopausal women aged 18 years and over, who had symptomatic bacterial vaginosis were randomly allocated to receive either clindamycin 2% cream 5 grams (107 patients) or matching placebo cream (114 patients), daily for three days. Response to therapy was assessed at 7 days (Visit 2) and 28 days (Visit 3). RESULTS--221 patients with symptomatic bacterial vaginosis were enrolled to the study and of these 141 (63.8%) completed the study. On the "intent-to-treat" (ITT) analysis, 75% of the clindamycin group were classified as "success" or "improved" at visit 2 compared with 13% of the placebo group (p < 0.001). At Visit 3, 41% of the clindamycin group were classified as either "success" or "improved" versus 4% in the placebo group (p < 0.001). Of the 80 patients who were recorded "success" or "improved" at visit 2, 20 (25%) were reported to have a "recurrence" of BV at Visit 3. The meta-analysis on those who were evaluable at Visit 2 and 3 also showed that clindamycin cream 2% was an effective treatment for bacterial vaginosis, and the differences between the clindamycin group and the placebo group were statistically significant. CONCLUSION--We conclude that a 3 day course of clindamycin 2% cream is an effective, and well tolerated treatment for bacterial vaginosis.     

复方甘草酸苷联合维A酸乳膏和糠酸莫米松乳膏治疗寻常性银屑病疗效观察

目的探讨复方甘草酸苷联合维A酸乳膏和糠酸莫米松乳膏治疗寻常性银屑病的临床疗效。方法165例患者随机分为两组,试验组81例,口服复方甘草酸苷联合维A酸乳膏和糠酸莫米松乳膏外用;对照组84例,仅外用维A酸乳膏和糠酸莫米松乳膏,疗程均为4周,随访3个月。结果试验组有效率为76．54％,明显高于对照组（48．81％）（P〈0．01）;试验组不良反应发生率为13．58％,比对照组低（20．24％）（P〈0．05）;试验组治愈患者复发率为24．00％,低于对照组（36．00％）（P〈O．05）。结论复方甘草酸苷联合维A酸乳膏和糠酸莫米松乳膏外用治疗寻常性银屑病疗效优于仅给予维A酸乳膏和糠酸莫米松乳膏外用,且患者不良反应和复发率明显降低。     

Local anesthetic effects of Lidocaine cream: randomized controlled trial using a standardized prick pain

Abstract Background: ELA-max? (4% Lidocaine) and EMLA? cream (Lidocaine-Prilocaine 2.5%) are topicals used for superficial anesthesia. Only few studies have been published on their comparative effectiveness in close-to-practice pain models. Objective: 1) To evaluate the analgesic efficacy of Lidocaine cream compared with Lidocaine-Prilocaine cream and placebo. 2) To assess the safety and tolerability. Methods: Randomized, three-arm, double-blind trial in 40 healthy volunteers comparing the anesthetic effects of Lidocaine and Lidocaine-Prilocaine cream to placebo at various time points (0-120 min). A standardized pain was induced by lancet pricks and measured by a visual analogue scale. Intra-individual comparison between the test areas was performed in a cross-over design. Results: Lidocaine showed significantly reduced pain compared to placebo at all assessment points. Pain reduction was achieved significantly earlier using Lidocaine occlusively (30 min). No significant differences were found concerning the anesthetic efficacy of Lidocaine and Lidocaine-Prilocaine cream. There were no relevant adverse events. Conclusion: This study confirms that a topical preparation with 4% Lidocaine is an effective and safe treatment option for superficial anesthesia. It supports the claim that an occlusive application is more rapid in action. 4% Lidocaine is of value as a rapidly-acting local anesthetic for the treatment of minor surgical procedures.