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 |
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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 |
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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 |
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Outcomes |
Primary outcomes
Secondary outcomes
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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 |