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AFTER - Treatment of women with Acne vulgaris - Evaluation of the eFficacy of isoTretinoin low-dose vs spironolactonE in the attack phase and spiRonolactone in the maintenance phase: A 2-step randomized controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520773-39-00
Enrollment
300
Registered
2026-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne in adult women

Brief summary

Efficacy will be evaluated with a co-primary endpoint at M6 1) First, with the GEA (Global Evaluation Assessment) severity score. GEA score assesses the comedones (open and closed), the non-inflammatory lesions, the papules and pustules and the nodules. The stage is defined according to a global evaluation of severity of acne and ranges from grade 0 (no acne) to grade 5 (the worst situation). The GEA score is detailed (see appendix 2).

Interventions

DRUGSPIRONOLACTONE
DRUGISOTRETINOIN
DRUGTRETINOIN
DRUGBENZOYL PEROXIDE
DRUGADAPALENE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Efficacy will be evaluated with a co-primary endpoint at M6 1) First, with the GEA (Global Evaluation Assessment) severity score. GEA score assesses the comedones (open and closed), the non-inflammatory lesions, the papules and pustules and the nodules. The stage is defined according to a global evaluation of severity of acne and ranges from grade 0 (no acne) to grade 5 (the worst situation). The GEA score is detailed (see appendix 2).—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 27, 2026