Oral zinc sulphate therapy in acne vulgaris: a double-blind trial

The effect of zinc sulphate and placebo was compared in a double-blind trial in 56 patients suffering from acne vulgaris. Serum vitamin A levels were studied in all, before and at the end of therapy, 29 patients received zinc sulphate 600 mg daily and 27 patients received placebo. Patients on placebo showed no improvement. After 12 weeks of treatment with zinc sulphate, 17 patients (58%) showed significant improvement. There was a statistically significant decrease in the number of papules, infiltrates and cysts. In zinc-treated cases there was statistically significant increase in serum vitamin A levels, while no change was found in the placebo group.     

Zinc sulfate in acne vulgaris.

The effects of orally administered zinc sulfate in 52 patients with mild to moderate acne vulgaris were compared to those of a placebo capsule. The numbers of comedones, papules, pustules, infiltrates, and cysts were counted at each visit over a 12-week period. Forty patients completed the study. Zinc appeared to have a somewhat beneficial effect on pustules but not on comedones, papules, infiltrates, or cysts. Fourteen patients (50%) in the zinc group had side effects of nausea, vomiting, or diarrhea. Six patients (21%) in the zinc group could not tolerate the nausea and withdrew from the study.     

The retinoic acid derivative Ro 11-1430 in Acne vulgaris. A controlled multicenter trial against retinoic acid.

In a double-blind controlled multicenter trial consisting of 257 patients with acne vulgaris an 8-week topical treatment with the retinoic acid derivative Ro 11-1430 (0.1% lotion) was compared with vitamin A acid (0.05% lotion) and the lotion alone (placebo). In reducing the number of comedones vitamin A acid was superior to Ro 11-1430, which was significantly better than placebo. The reduction in number of papules and pustules was not statistically significant on either treatment. Local side effects, i.e. erythema, desquamation, burning and pruritus occurred more frequently and were more severe on vitamin A acid than on Ro 11-1430 and placebo which did not differ. No correlation was found between incidence and severity of local reactions and therapeutic effect.     

Oral zinc therapy of acne. Absorption and clinical effect.

In a double-blind controlled comparison that lasted eight weeks, tablets of zinc sulfate monohydrate, 411 mg total daily dosage, and a lactose placebo were administered orally to 22 male subjects with moderate acne. At the same time, levels of zinc were determined in serum and urine. There were no statistically significant differences in the lesion counts (papules, pustules, open comedones, and closed comedones) in the zinc-treated and lactose-treated cases, despite evidence in serum and urine of absorption of zinc. The data from this study indicate that oral zinc therapy has no early clinical effect on male patients with moderate acne.     

A double-blind trial of a zinc sulphate/citrate complex and tetracycline in the treatment of acne vulgaris

Forty-eight patients participated in a 3-month double-blind study to compare the effect of orally administered zinc sulphate/citrate complex and tetracycline hydrochloride in acne vulgaris. Tetracycline significantly reduced the overall grade, and the number of non-inflamed lesions, papules and pustules by the third month. It also reduced significantly the non-inflamed lesions and papules at the end of the second month. In contrast, zinc therapy only had a significant effect on the pustules at the third month. The results indicate that tetracycline is far superior to the zinc complex in patients with moderately severe acne.     

A 4% erythromycin and zinc combination (Zineryt®) versus 2% erythromycin (Eryderm®) in acne vulgaris: a randomized, double-blind comparative study

A double-blind, randomized multi-centre study was performed to evaluate the efficacy of a 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm). One-hundred and twenty-two patients suffering from acne vulgaris were treated with either Zineryt lotion or 2% erythromycin lotion. Acne grading and lesion counts for comedones, papules, pustules, nodules and macules were performed at each visit at 0, 1, 2, 4, 8 and 12 weeks. Treatment with Zineryt lotion was found to be more effective than with 2% erythromycin as regards the reduction in number of the acne lesions and the severity grade of the acne.     

Meclosorb, a new topical antibiotic agent in the treatment of acne vulgaris: a double-blind clinical study

The clinical effect on acne vulgaris of topical treatment with meclocycline sulfosalicylate and systemic treatment with peroral tetracycline (500 mg daily) was compared in a double-blind study of 60 patients treated for 8 weeks. The reducing effect of Meclosorb cream and tetracycline tablets on the number of closed comedones, pustules, papules and cysts was marked and not significantly different. The effect of Meclosorb on open comedones was weak and of slow onset. No side effects were registered. Topical treatment with Meclosorb is an effective and safe alternative to systemic tetracycline treatment of acne vulgaris.     

Acne treatment with oral zinc and vitamin A: effects on the serum levels of zinc and retinol binding protein (RBP).

The serum levels of zinc, vitamin A and retinol binding protein (RBP) were studied in 75 acne patients before and during oral treatment with zinc, vitamin A or placebo. In the zinc-treated patients an increase in the mean serum zinc level was seen after 2 weeks, when also the first clinical improvement occurred. After 4 weeks the zinc level had increased by about 30% and no further significant increase was observed during 3 months of treatment. In 33 healthy subjects there was an increase of 14% after 4 weeks of zinc therapy. Vitamin A and placebo induced no significant changes in the serum zinc status. Prior to therapy the serum levels of vitamin A and RBP were lower in the acne patients than in the controls. Zinc + vitamin A treatment raised the serum RBP value to normal after 4 weeks. In patients given vitamin A alone, a probable increase in RBP was achieved. Zinc and placebo treatment did not change the serum level of RBP.     

Randomized controlled study of a cosmetic treatment for mild acne

Background. Cosmetic products are not tested with the same rigour as medical treatments, but recent high‐quality studies have shown significant reductions in changes of skin ageing with use of cosmetic antiageing products. Aim. To test whether a cosmetic ‘anti‐spot’ two‐step treatment containing a complex of seaweed‐derived oligosaccharide and zinc would produce a significant improvement in mild acne. Methods. A double‐blind, vehicle‐controlled trial of this treatment was performed for 8 weeks on 60 age‐matched participants with mild acne. They were divided into two groups: 30 participants were treated with vehicle control and 30 with the active treatment containing a seaweed‐derived oligosaccharide complexed with 0.1% zinc pyrrolidone. Results. After 8 weeks, both groups had a reduction in comedones, papules and pustules, and this was significantly greater in the active than control group at 2, 4 and 8 weeks. Conclusions. Cosmetic products may offer some benefit for mild acne and still meet the requirements of the European Cosmetic Directive. In particular, the seaweed‐derived oligosaccharide complexed with 0.1% zinc pyrrolidone used in this study produced a significant reduction in acne vs. a control treatment. Cosmetic companies should conduct blinded controlled trials of their product’s efficacy and publish the results.     

Efficacy and safety study of two zinc gluconate regimens in the treatment of inflammatory acne

This double-blind study was conducted on 67 patients with inflammatory acne who received one of two zinc gluconate regimens (Rubozinc) for three months. One was a constant-dose regimen and the other included an initial three-week loading dose, but both regimens provided the same cumulative dose at three months. The primary assessment criteria was the change with respect to baseline in the total number of superficial inflammatory lesions (papules and pustules). The two treatment groups were not statistically significantly different, with respect to this criteria, after three, five, seven or thirteen weeks of treatment. Therefore, the regimen that included a loading-dose provided no additional benefit. The results of this study are in favor of the conventional therapeutic regimen of two capsules daily for three months, as defined in the marketing authorization.     

An observational study of methionine‐bound zinc with antioxidants for mild to moderate acne vulgaris

APC is a novel methionine‐based zinc complex with antioxidants that has been used in acne as a nutritional supplement. This is based on the proven role of zinc and antioxidants in improving acne, specially the inflammatory lesions. The objectives of this study are to explore the efficacy, safety, and tolerability of APC in acne patients with mild to moderate facial acne vulgaris. In this exploratory trial, 48 patients were treated with oral APC thrice a day for 3 months followed by a 4‐week treatment‐free period. At the end of treatment (Week 12), there was a statistically significant improvement in the global acne count (p < 0.05), which began after 8 weeks (p < 0.05). Almost 79% (38/48) of the patients had 80–100% improvement. There was a significant reduction in pustules (8 weeks (p < 0.05) and 12 weeks (p < 0.001)), and papules and closed comedones (8 weeks (p < 0.05) and 12 weeks (p < 0.001)). Only two patients had side effects. The current data indicate that treatment with oral APC thrice daily for 12 weeks in patients with mild to moderate facial acne vulgaris is efficacious and well tolerated. As the onset of action is late, concomitant topical therapy can enhance the results.     

Water-based versus alcohol-based benzoyl peroxide preparations in the treatment of acne vulgaris

Forty-eight patients with acne vulgaris in the face were treated with a water-based (Basiron) and an alcohol-based (Panoxyl) 5% benzoyl peroxide preparation. A randomized double-blind, contralateral study was used. No difference in clinical effect was found. Treatment for 8 weeks resulted in at least 50% reduction in the number of closed comedones, papules and pustules in over 80% of the patients. In more than 70% of the patients, the reduction exceeded 75%. The water-based Basiron caused significantly less skin irritation than the alcohol-based preparation of Panoxyl.     

Clinical efficacy and safety of a topical combination of retinaldehyde 0.1% with erythromycin 4% in acne vulgaris

The objective of this randomized, controlled, multicentre study was to assess the efficacy and safety of a topically applied retinaldehyde 0.1% gel in combination with a topical erythromycin 4% lotion for the treatment of acne vulgaris. Treatment consisted of applying either retinaldehyde or its vehicle every morning and erythromycin every evening for 8 weeks. Efficacy parameters were sequential lesion counts for papules and pustules, and a 6-point semiquantitative scale for comedones and microcysts. Safety parameters were local tolerance and adverse events. Of 74 recruited patients, 73 were appraisable for efficacy and safety. In both treatment groups, papules and pustules were reduced significantly at the end of treatment (P < 0.001), and no statistical difference was observed between the groups. Comedones and microcysts were significantly improved with retinaldehyde combined with erythromycin (P = 0.005), but not with erythromycin alone. However, no statistical difference between the groups could be demonstrated (test power, 50%). Local tolerance of the combined treatment group was very satisfactory, as only a few patients experienced local irritation. In conclusion, retinaldehyde combined with erythromycin appears to be a valuable topical therapy in polymorphic acne.     

A clinical trial comparing the safety and efficacy of a topical erythromycin-zinc formulation with a topical clindamycin formulation

One hundred three patients with acne vulgaris were randomly designated to receive either a topical formulation of erythromycin plus zinc or a topical solution of 1% clindamycin phosphate (Cleocin-T). The patients treated themselves twice daily and were examined at 3, 6, 9, and 12 weeks after the start of therapy. By week 6 the overall severity grade was consistently lower and the percent reduction of severity, papules, pustules, and total comedones was higher in the erythromycin-zinc-treated group than in the clindamycin-treated group. In the 92 patients who completed this study (48 receiving erythromycin-zinc and 44 receiving clindamycin), no serious topical or systemic side effects were reported. Two patients, one from each treatment group, suffered mild irritation. One patient was withdrawn from the erythromycin-zinc-treated group. Results of patch tests were negative. The superiority of the erythromycin-zinc formulation may be due to the increased (4%) erythromycin concentration and/or the ability of 1.2% zinc acetate to enhance the product's activity.     

Oral zinc sulphate therapy for acne vulgaris.

A double-blind controlled clinical trial was performed to evaluate the effect of oral zinc sulphate, 0.6 g daily, on acne vulgaris. Twenty patients received zinc sulphate tablets and 19 were given placebo tablets. Thirteen of the zinc group and 12 of the placebo group received their medication throughout a 12-week period, while the remaining patients were treated for 4 or 8 weeks. In all patients the numbers or papular and pustular acne lesions on the face and the back were significantly reduced, while larger infiltrates remained practically unaltered during the trial, which was performed from March through May 1975. No statistically significant difference in the improvement of the groups was demonstrable. Pretreatment serum zinc values, which were normal in all patients, rose significantly in the zinc group as well as in the control group, but the increase in the former was significantly higher. The negative therapeutical results might be attributable to the limited number of patients or related to the zinc dosage. Furthermore, the results might have been influenced by the unexplained rise in serum zinc values in the control group. A possible weak beneficial effect of zinc might also have been camouflaged by the seasonal variation in the severity of acne which was noted in this study.     

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.     

Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris

BACKGROUND: In addition to tetracyclines, zinc may constitute an alternative treatment in inflammatory lesions of acne. OBJECTIVE: To evaluate the place of zinc gluconate in relation to antibiotics in the treatment of acne vulgaris. METHODS: Zinc was compared to minocycline in a multicenter randomized double-blind trial. 332 patients received either 30 mg elemental zinc or 100 mg minocycline over 3 months. The primary endpoint was defined as the percentage of the clinical success rate on day 90 (i.e. more than 2/3 decrease in inflammatory lesions, i.e. papules and pustules). RESULTS: This clinical success rate was 31.2% for zinc and 63.4% for minocycline. Minocycline nevertheless showed a 9% superiority in action at 1 month and one of 17% at 3 months, with respect to the mean change in lesion count. Regarding safety, the majority of the adverse effects of zinc gluconate and of minocycline concerned the gastrointestinal system and were moderate (5 dropouts with zinc gluconate and 4 with minocycline). CONCLUSION: Minocycline and zinc gluconate are both effective in the treatment of inflammatory acne, but minocycline has a superior effect evaluated to be 17% in our study.     

The comparative efficacy of benzoyl peroxide 5%/erythromycin 3% gel and erythromycin 4%/zinc 1.2% solution in the treatment of acne vulgaris

This randomized 10–week study compared the efficacy of benzoyl peroxide 5%/erythromycin 3% gel with erythromycin 4%/zinc 1.2% solution in 72 acne vulgaris patients. Physician global evaluations were significantly more improved (P 0.05) in the benzoyl peroxide 5%/erythromycin 3% gel treatment group compared to erythromycin 4%/zinc 1.2% solution at week 2 and at each subsequent biweekly clinical visit. Inflammatory lesions (papules/pustules) were significantly more reduced (P 0.005) in the benzoyl peroxide 5%/erythromycin 3% gel treatment group than the erythromycin 4%/zinc 1.2% solution at weeks 4 and 10. Comedones were significantly more reduced (P 0.001) in the benzoyl peroxide 5%/erythromycin 3% gel treatment group than in the erythromycin 4%/zinc 1.2% solution group at weeks 8 and 10. Patient efficacy evaluations significantly (P 0.001) favoured benzoyl peroxide 5%/erythromycin 3% gel to erythromycin 4%/zinc 1.2% solution.     

异维A酸红霉素凝胶治疗寻常痤疮的多中心随机对照临床研究

目的 比较异维A酸红霉素凝胶与阿达帕林凝胶治疗轻中度寻常痤疮的疗效和安全性。方法 多中心、开放、随机、平行对照研究。按照中国痤疮治疗指南痤疮严重程度标准入选轻、中度（Ⅰ ~ Ⅲ级）寻常痤疮患者192例,纳入疗效分析169例,安全性分析190例。试验组86例,外用异维A酸红霉素凝胶;对照组83例,外用阿达帕林凝胶,均为每晚1次,共用药6周。在基线、治疗2、4和6周时分别记录患者白头粉刺、黑头粉刺、炎性丘疹、脓疱数,评价各时间点患者痤疮严重程度,同时记录皮肤局部耐受性以及其他不良反应。结果 随着治疗时间延长,两组的有效率逐渐提高,总体病情严重程度改善。在治疗6周时,试验组总有效率为51.16%,对照组为40.96%,两组差异无统计学意义（P > 0.05）;但在治疗4周及6周时,试验组患者脓疱及炎性皮损的疗效优于对照组（P < 0.05）,同时试验组痤疮分级较对照组低（P < 0.01）。两组不良反应类似,均表现为局部刺激,可耐受。结论 异维A酸红霉素凝胶治疗轻、中度寻常痤疮总有效率与阿达帕林凝胶类似,对于炎性损害疗效优于阿达帕林凝胶,并且对患者总体严重程度降低更快。     

寻常痤疮细菌感染病因学探讨

对１３２例寻常痤疮患者的皮损内容取材，同时进行需氧菌和厌氧菌培养。其中有１１２例分离到细菌，细菌培养阳性率８４．８％。１１２例共分离出１３７株细菌，其中需氧菌７５株，厌氧菌６２株，痤疮丙酸杆菌的分离率为４２．３％。１１２例中５８例分离到痤疮丙酸杆菌，阳性率为５１．８％；２４例为混合感染。１６例用特丽仙溶液治疗６周后，细菌培养阴转率为７５．０％；脓疱、丘疹、粉刺数的平均值分别由２．０６、１７．６９和２３．６３个减至０．７５、３．６３和１５．５６个。结果证明细菌感染在寻常痤疮病因学中的作用。