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

Hunt 1992.

Study characteristics
Methods Aim of study: to compare the efficacy and skin tolerance of a topical alpha hydroxy acid preparation gluconolactone 14% in solution, with its vehicle alone (placebo) and 5% BPO lotion in treatment of mild to moderate acne
Design: parallel
Unit of allocation: patients
Allocation: randomisation; no details
Blinding: blinding for participants, investigators and assessors
Duration of trial (from recruitment to last follow‐up): not described
Dropouts: 15 dropouts with reasons; 4 discontinued due to irritation of the skin
Participants Population description: mild to moderate acne
Setting: not described
Randomised number: 150
Age: 20.1 (13 to 36) years
Sex: 76/74
Severity of illness: mild to moderate
Interventions Name of treatment group: alpha‐hydroxy acid group. n = 50
Description: alpha hydroxy acid preparation gluconolactone 14% in aqueous solution (formulation developed by Narhex Australia Pty Ltd)
Treatment period: not described
Timing: not described
Name of control group 1: placebo group. n = 50
Description: the vehicle of treatment group
Treatment period: not described
Timing: not described
Name of control group 2: BPO group. n = 50
Description: 5% BPO water‐based lotion
Treatment period: not described
Timing: not described
Outcomes Primary outcomes
  • Participants' global self‐assessment of acne improvement (e.g. measured by a 4‐point scale: excellent, good, fair, and poor). Authors did not report this outcome.

  • Withdrawal for any reason (15 withdrawals during 12 weeks' study)


Secondary outcomes
  • Change in lesion counts (total or inflamed and non‐inflamed separately). From baseline to week 12, percentage reduction of lesion counts.

  • 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)

  • Skin reactions were graded using a 4‐point scale (0‐nil, 1‐mild, 2‐moderate to 3‐severe). Reported number of participants who experienced minor adverse events.

  • Quality of life. Authors did not report this outcome.

Notes Funding: Narhex Australia Pty Ltd
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the patients were randomised into three treatment groups..."
Comment: but no details of random methods were described
Allocation concealment (selection bias) Unclear risk Although "identical numbered packages" were used here, no more details for enough concealment were described.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "All treatments were supplied in 100 ml aliquots, pre‐packed in identical numbered packages...both doctor and patients were blinded".
Comment: blinding probably sufficient
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "...and patients were instructed not to describe to the assessing doctor any characteristics of the product such as colour, smell or consistency"
Comment: blinding probably sufficient
Incomplete outcome data (attrition bias)
All outcomes Low risk A total of 15 (10%) dropouts with reasons; number of missing data not considered enough to introduce bias significantly
Selective reporting (reporting bias) Unclear risk Insufficient data regarding "adverse events"
Other bias High risk Suspicious baseline imbalance in total lesion counts among groups (76.8 ± 7.5 in gluconolactone group; 94.7 ± 11.1 in placebo group; 76.5 ± 7.0 in BPO group); the use of a Student's t‐test with no posthoc analysis to compare the means of lesions of three treatment groups