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Cls7.0
Clascoterone Research
Mostly mechanism / observational
9 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Clascoterone 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 2011–2024 with a typical study size of 609 participants.
Based on 9 studies · 2 meta-analyses · 4 RCTs · 8,484 total participants
Confidence
High confidence
By outcome
Skin healthTreatment success (clear or almost clear with a 2-grade improvement) in about 20% of patients at 12 weeks versus about 8% on vehicle; comedonal lesions respond more reliably than inflammatory ones · 12 weeks · Reduced total lesion count and acne severity in moderate-to-severe facial acne; no evidence for general skin quality outside acne · 12 weeks
Mostly mechanism / observational7 studies
Anxiety & stress
Too few graded studies2 studies
Safety profile
Too few graded studies2 studies
Active research area
4 studies in the last 5 years · Latest meta-analysis: 2024
201120172024
1RCTCited 110×n=1,440 · large study2020
In plain English: Two identical multicentre, vehicle-controlled, double-blind phase 3 studies (CB-03-01/25 and CB-03-01/26) randomised 1440 patients aged 9 years and older with moderate or severe facial acne to clascoterone cream 1% or vehicle twice daily for 12 weeks.
Hebert A, et al. · JAMA Dermatol (2020)
The pivotal registration trials: two identical phase 3 studies, 1440 patients randomised, conducted November 2015 to April 2018.
Eligibility required 30-75 inflammatory and 30-100 noninflammatory lesions, so the result speaks to moderate-to-severe disease rather than mild acne.
Treatment success was defined as an IGA of 0 or 1 PLUS a 2-grade or greater improvement — a stricter endpoint than "improved".
2RCTCited 6×n=1,421 · large study2023
In plain English: In a pooled analysis of the two phase 3 trials restricted to patients aged 12 years and over, treatment success at week 12 was 19.9% with clascoterone versus 7.7% with vehicle.
Eichenfield L, et al. · J Drugs Dermatol (2023)
709 patients received clascoterone and 712 received vehicle in the pooled ≥12-year population.
Treatment success 19.9% vs 7.7% — a real difference, and also a reminder that four in five treated patients did NOT reach clear or almost clear at 12 weeks.
Absolute change from baseline: noninflammatory lesions -20.8 vs -11.9, inflammatory -19.7 vs -14.0, total -40.0 vs -26.1 (all P<0.0001).
3Meta-AnalysisCited 12×n=2,457 · very large study2021
In plain English: Pooling five trials (2457 patients), clascoterone increased IGA success (RR 2.87, 95% CI 2.11-3.89) and reduced noninflammatory lesions (MD -5.64), but did NOT significantly change inflammatory lesion counts (MD -1.82, 95% CI -5.06 to 1.43, P = .27).
Ibrahim O, et al. · Dermatol Ther (2021)
Five trials, 2457 patients (1357 clascoterone, 1100 placebo), overall low risk of bias.
⚠️ The inflammatory-lesion result was NULL: MD -1.82, 95% CI -5.06 to 1.43, P = .27. The confidence interval crosses zero.
Noninflammatory (comedonal) lesions did improve: MD -5.64, 95% CI -8.41 to -2.87.
4Meta-AnalysisCited 6×n=2,006 · very large study2024
In plain English: Topical clascoterone 1% twice daily reduced inflammatory (SMD -0.27) and noninflammatory (SMD -0.31) lesion counts versus placebo, while oral spironolactone 200 mg reduced TOTAL lesion count by SMD -4.46 — different outcomes, so the two figures are not directly comparable.
Abdelmaksoud A, et al. · PLoS One (2024)
Indirect comparison with oral spironolactone, the established systemic antiandrogen for acne.
⚠️ The effect sizes are on DIFFERENT outcomes: clascoterone's -0.27/-0.31 are inflammatory and noninflammatory counts, spironolactone's -4.46 is total lesion count. Read as a potency ratio it would overstate the gap.
Clascoterone was significantly associated with 12-week treatment success versus placebo (OR 2.44, 95% CI 1.12-5.30).
5RCTCited 21×n=363 · medium study2019
In plain English: In 363 subjects, week-12 treatment success was 8.6% for clascoterone 1% twice daily and 8.3% for 0.1% twice daily, versus 2.7% for vehicle.
Trifu V, et al. · J Drugs Dermatol (2019)
The dose-finding study that selected the 1% twice-daily regimen.
⚠️ On the TREATMENT SUCCESS endpoint the dose-response was flat: 1% BID (8.6%) barely differed from 0.1% BID (8.3%) across a tenfold concentration range. Lesion counts did improve with dose.
Absolute change in inflammatory (P=0.0431) and noninflammatory (P=0.0303) lesions was significant ACROSS treatment groups, not as a clascoterone-versus-vehicle contrast.
6Open-LabelCited 29×n=609 · large study2020
In plain English: Across up to 9 months of twice-daily use on face and/or trunk in 609 enrolled patients, 110 (18.1%) experienced a treatment-emergent adverse event, and the 7 serious events in 6 patients were none of them treatment related.
Eichenfield L, et al. · J Am Acad Dermatol (2020)
The long-term safety anchor: up to 9 MONTHS of continuous twice-daily use (not 12).
609 enrolled, 347 completed. 18.1% had a treatment-emergent adverse event; nasopharyngitis was the most common (n=20).
Local skin reactions occurred in 18.1% (110/607) — most commonly erythema, scaling/dryness and pruritus, most trace/minimal or mild.
7Open-LabelCited 3×n=69 · small study2024
In plain English: Under maximum-use exposure for 14 days, 5 of 69 clascoterone-treated patients had an abnormal cosyntropin stimulation test at day 14, and all had normal cortisol at follow-up roughly 4 weeks later.
Eichenfield L, et al. · J Drugs Dermatol (2024)
The specific safety question for a topical antiandrogen: does it suppress the adrenal axis? Answer — mildly and reversibly, under maximum-use conditions.
5/69 abnormal at day 14: 1/20 adults, 2/22 aged 12 to <18, 2/27 aged 9 to <12. Younger patients were not exempt.
All abnormal results normalised at follow-up; no clinically relevant adverse events accompanied them.
8RCTCited 47×n=77 · small study2011
In plain English: Seventy-seven men with facial acne were randomised to placebo (n=15), CB-03-01 1% cream (n=30) or tretinoin 0.05% cream (n=32) once daily for 8 weeks; CB-03-01 was significantly better than placebo for total lesion count (P=0.0017), inflammatory lesion count (P=0.0134) and acne severity index (P=0.0090).
Trifu V, et al. · Br J Dermatol (2011)
The earliest human trial in this set, published under the development name CB-03-01.
MEN ONLY (n=77: placebo 15, CB-03-01 30, tretinoin 32), 8 weeks, applied once daily at bedtime.
Significantly better than placebo for total lesion count (P=0.0017), inflammatory lesion count (P=0.0134) and acne severity index (P=0.0090).
9Open-LabelCited 28×n=42 · small study2019
In plain English: In 42 subjects applying clascoterone 1% cream twice daily for 14 days, 3 of 42 (7%) showed an abnormal HPA axis response; clascoterone is rapidly metabolised to cortexolone in human plasma.
Mazzetti A, et al. · J Drugs Dermatol (2019)
Explains WHY systemic effects are limited: clascoterone is rapidly metabolised to cortexolone in plasma.
42 subjects in two cohorts — 20 adults over 18, 22 aged 12-18 — applying 1% cream twice daily for 14 days.
3 of 42 (7%) demonstrated an abnormal HPA axis response over 14 days — laboratory evidence, reported without clinical adrenal suppression.