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. 2020 May 1;2020(5):CD011368. doi: 10.1002/14651858.CD011368.pub2

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
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)
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
Outcomes Primary outcomes
  • Participants' global self‐assessment of acne improvement (e.g. measured by a four‐point scale: excellent, good, fair, and poor). Authors did not report this outcome

  • Withdrawal for any reason. 12 withdrawals during the 8‐week treatment period


Secondary outcomes
  • Change in lesion counts (total or inflamed and non‐inflamed separately). Reduction of inflamed and non‐inflamed lesions, week 8

  • Physicians' global evaluation of acne improvement. Authors did not report this outcome

  • Minor adverse events (assessed as total number of participants who experienced at least one minor adverse event). Reported percentage of participants who experienced minor adverse event

  • Quality of life. Authors did not report this outcome


Other outcomes that were not analysed in this review
  • Intensity of seborrhoea

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