ArticleClinical pharmacology in drug development2025
Pharmacokinetics, Safety, and Skin Irritation and Sensitization Potential of Clascoterone Cream in Early-Phase Clinical Study Participants.
Article in Clinical pharmacology in drug development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Soft drugs: design principles and topical applications.Nature reviews. Drug discovery · 2026Review
- Clascoterone in the Treatment of Acne Vulgaris: A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clascoterone is an androgen receptor inhibitor approved for the treatment of acne vulgaris in patients 12 years of age and older. Here, we report results of 5 phase 1 studies that assessed the pharmacokinetics (PK), safety, and skin irritation and sensitization potential of clascoterone cream 1% in healthy participants and patients with acne. Studies CB-03-01/02 (EudraCT: 2007-005064-28) and CB-03-01/04 (n = 24 each) assessed PK in healthy participants. Study 171-7151-203 (n = 8) assessed steady-state PK in patients with acne. Studies CB-03-01/05 (n = 36) and CB-03-01/32 (n = 250) assessed skin irritation and sensitization potential, respectively, in healthy participants. Systemic exposure to clascoterone was low after repeated daily application for up to 42 days of treatment. Clascoterone was excreted in urine as conjugated esters at a ≤1% fraction of the administered dose. Adverse events and local skin reactions were generally mild/moderate and reversible. No clinically relevant changes were observed in laboratory tests and vital signs. Skin irritation and sensitization with clascoterone treatment were minimal. Phase 1 study findings supported low systemic absorption of clascoterone and a favorable safety profile after topical application of clascoterone cream 1%, with no evidence of irritation or sensitization.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.