Weltert 2004.
Study characteristics | ||
Methods |
Aim of study: to compare the efficacy of nicotinamide to a reference comparative product in the local treatment of moderate acne with a predominant inflammatory component, i.e. erythromycin Design: parallel, active control Unit of allocation: individuals Allocation: randomisation; no details Blinding: unclear Duration of trial (from recruitment to last follow‐up): not described Dropouts: 7 in treatment; 5 in control |
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Participants |
Population description: acne with inflammatory predominance Setting: Laboratoire Dermscan (Villeurbanne), France, all subjects were Caucasian. Randomised number: 158 Age: 19.0 +/‐ 2.7 in treatment; 19.3 +/‐ 2.9 in control Sex (M/F): 29/50 in treatment; 29/50 in control Severity of illness: moderate inflammatory acne on face (≥ 5 inflammatory elements, papules or pustules) |
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Interventions |
Name of treatment group: 4% nicotinamide gel; n = 79 Description: product: Exfoliac NC Gel (Merck Medication Familiale, France) Galenic form: gel Formula: active ingredient: niacinamide 4% Excipients: aqua, alcohol denat., laureth‐12, magnesium aluminium silicate, hydroxypropyl methyl cellulose, citric acid Treatment period: 8 weeks Timing: twice daily Name of treatment group: erythromycin; n = 79 Description: erythromycin, titre 1000 UI/mg Galenic form: liquid gel for local application Formula: active ingredient: erythromycin 4% Excipients: 96% ethyl alcohol, hydroxypropyl cellulose Treatment period: 8 weeks Timing: twice daily |
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Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes that were not analysed in this review
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Notes | Funding: not mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Although 'randomised' was mentioned, no details were reported for random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 and 5 dropouts in treatment and control group. No imputation method reported, but number of missing data not considered as likely to introduce bias significantly |
Selective reporting (reporting bias) | Unclear risk | Insufficient data regarding "Safety" assessed through clinical scoring |
Other bias | Low risk | No other potential bias identified |
all‐TRA: all‐trans retinoic acid AQOL: Acne quality of life AV: acne vulgaris AZA: azelaic acid BPO: benzoyl peroxide CDP: clindamycin phosphate CLN: clindamycin ITT: intention‐to‐treat MAS: Michaelsson acne severity RA: retinoic acid SA: salicylic acid SD: standard deviation