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Dps6.0
Dapsone (topical) Research
Mostly mechanism / observational
10 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Dapsone (topical) studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2007–2026 with a typical study size of 3,010 participants.
Based on 10 studies · 2 meta-analyses · 6 RCTs · 44,697 total participants
Confidence
High confidence
By outcome
Skin healthTreatment success in roughly 40-69% over 12-16 weeks on the 5% gel, with inflammatory lesions responding more than comedones. Measurably better in women than men. Positioned as an alternative after first-line therapies rather than instead of them. · 2-12 weeks
Mostly mechanism / observational9 studies
Safety profile
Mostly mechanism / observational3 studies
Anemia & hematology
Too few graded studies2 studies
Active research area
4 studies in the last 5 years · Latest meta-analysis: 2026
200720162026
1Meta-Analysisn=22,645 · very large study2026
In plain English: Compared with placebo, only dapsone 5% and erythromycin 2% significantly reduced inflammatory lesion counts. … However, no treatment showed a significant improvement in total lesion counts compared to placebo.
Not stated in the abstract · Clin Drug Investig (2026)
32 studies comprising 34 randomised controlled trials, 22,645 patients, searched to October 2025.
⚠️ CLINDAMYCIN WAS NOT AMONG THE AGENTS that significantly reduced inflammatory lesion counts against placebo. Only dapsone 5% and erythromycin 2% were.
⚠️ Nor was it among those reducing non-inflammatory lesions: azithromycin 2%, erythromycin 2%, metronidazole 2% and minocycline 4% were.
2RCTCited 69×n=3,010 · very large study2007
In plain English: Dapsone gel-treated patients achieved superior results in terms of the investigator's global acne assessment (P < .001) and the mean percentage reduction in inflammatory, noninflammatory, and total lesion counts (all, P < .001) at week 12.
Draelos ZD, et al. · J Am Acad Dermatol (2007)
Two identically designed 12-week randomised double-blind vehicle-controlled studies, 3,010 patients aged 12 and over, twice-daily monotherapy.
Reductions in inflammatory lesions favouring dapsone were apparent as early as 2 weeks and statistically significant by 4.
⚠️ The abstract reports P VALUES ONLY and gives no absolute percentage reductions, so the size of the benefit cannot be read from it.
3Meta-AnalysisCited 10×n=11,424 · very large study2022
In plain English: Meta-analysis showed that dapsone gel alone or dapsone gel combined with isotretinoin was superior to excipient alone or oral isotretinoin alone in the treatment of acne (OR =1.51, 95% CI: 1.38-1.66, P<0.0001 random effects model, I2=0%).
Not stated in the abstract · Ann Palliat Med (2022)
7 trials, 11,424 participants, searched across seven databases including four Chinese-language ones.
Odds ratio 1.51 (95% CI 1.38 to 1.66) with I-squared of 0%, which is unusually consistent for a topical acne literature.
Dapsone was MORE effective in female patients: OR 1.80 (95% CI 1.46 to 2.23).
4RCTCited 29×n=2,898 · very large study2012
In plain English: The mean reduction in total lesion counts in dapsone-treated females and males was, respectively, 46.6% vs 35.8% (P<.0001). … Significantly more dapsone-treated females than males achieved clinical success (48.6% vs 34.4%; P=.0003).
Tanghetti E, et al. · J Drugs Dermatol (2012)
POST-HOC pooled analysis of the two identical phase 3 vehicle-controlled trials (DAP0203 and DAP0204), 2,898 patients, US and Canada, 2002-2003. Sex was not randomised.
1,453 received dapsone (753 female, 700 male) and 1,445 received vehicle, assessed at weeks 2, 4, 6, 8 and 12.
REDUCTIONS in papulopustular and comedonal lesion counts were likewise significantly greater in female than male patients (each P < .0001).
5Systematic ReviewCited 5×2022
In plain English: Dapsone monotherapy showed a treatment success rate of 40.1-69.4% for dapsone gel 5% and 29.8-47.0% for dapsone gel 7.5% when used for 12-16 weeks.
Not stated in the abstract · Int J Dermatol (2022)
14 studies, searched across PubMed, Embase and the Cochrane Library.
Treatment success 40.1-69.4% for the 5% gel and 29.8-47.0% for the 7.5% gel over 12-16 weeks.
⚠️ The HIGHER concentration shows the LOWER success range. The review notes variable treatment regimens make comparison across studies difficult, so this is not a like-for-like contrast.
6RCTCited 42×n=64 · small study2008
In plain English: After treatment with dapsone gel, 5%, no clinical or laboratory evidence of drug-induced hemolytic anemia was noted in G6PD-deficient subjects with acne vulgaris.
Piette WW, et al. · Arch Dermatol (2008)
Double-blind randomised vehicle-controlled CROSSOVER study in 64 patients aged 12 and over who had both G6PD deficiency and acne, with a 2-week washout between 12-week periods.
A 0.32 g/dL fall in haemoglobin occurred from baseline to 2 weeks on dapsone, was not accompanied by changes in reticulocytes, haptoglobin, bilirubin or lactate dehydrogenase, and was no longer apparent at 12 weeks.
The number of patients with a 1 g/dL drop was similar between treatments at both 2 and 12 weeks, and the largest single drop was in the VEHICLE group (1.7 g/dL against 1.5 g/dL on dapsone).
7RCTCited 10×n=4,327 · very large study2018
In plain English: Dapsone gel, 7.5% significantly reduced inflammatory, comedonal, and total lesions in skin phototypes I-III (P less than .001) and IV-VI (P less than equal to .01) versus vehicle.
Alexis AF, et al. · J Drugs Dermatol (2018)
Pooled data from two identically designed phase 3 randomised double-blind vehicle-controlled studies, once daily for 12 weeks, patients aged 12 and over with moderate acne.
2,216 patients with Fitzpatrick phototypes I-III and 2,111 with types IV-VI, so the darker-skin group was close to half the pooled population.
Significant improvement in both phototype subgroups on global assessment (both P < .0001) and on lesion counts.
8ReviewCited 13×2012
In plain English: The mean reduction from drugs and vehicles were 42 ± 7.1%, and 23 ± 5.0%, respectively; the mean contribution of vehicle toward drug effect was 55 ± 15% (range 35 - 82%).
Chiou WL · Int J Clin Pharmacol Ther (2012)
⚠️ THE MOST UNCOMFORTABLE PAPER IN THIS SET, and it is about the whole topical acne category rather than dapsone alone.
Evaluated the vehicle's percentage contribution to reported efficacy for 8 commonly prescribed topical preparations at 10-12 weeks, 5% dapsone among them.
Drug arms averaged 42% total lesion reduction against 23% for vehicle arms, putting the vehicle's contribution at a mean 55% and a range of 35% to 82%.
9RCTCited 25×n=301 · medium study2010
In plain English: The authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination).
Fleischer AB, et al. · J Drugs Dermatol (2010)
301 patients aged 12 and over applied dapsone gel twice daily and were randomised 1:1:1 to adapalene, benzoyl peroxide or MOISTURISER once daily for 12 weeks.
⚠️ NULL ON THE MAIN COMPARISON: neither active partner significantly beat plain moisturiser for inflammatory lesion reduction (P = 0.052 for both).
The adapalene combination DID significantly beat the moisturiser combination on non-inflammatory and total lesion counts.
10RCTCited 3×n=28 · very small study2024
In plain English: The therapeutic response between the studied groups was statistically significant in favor of the topical spironolactone group.
Not stated in the abstract · Arch Dermatol Res (2024)
28 patients with mild-to-moderate acne randomised to topical spironolactone 5% gel or topical dapsone 5% gel, twice daily for 12 weeks.
⚠️ DAPSONE LOST. Response in the dapsone arm was poor in 50%, moderate in 42.9% and good in 7.1%, with none rated excellent. Spironolactone: poor 14.3%, moderate 28.6%, good 50%, excellent 7.1%.
Itching was significantly more common with dapsone; burning was the complaint with spironolactone.