Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05891795 · ClinicalTrials.gov registry record · Phase 1
Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
A Phase 1 study of Acne Vulgaris, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05891795: Recruiting Phase 1 study of Acne Vulgaris, sponsored by Stanford University.
NCT05891795 is a Phase 1 study of Acne Vulgaris that is actively recruiting participants, run by Stanford University. The registered enrollment target is 18 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05891795, a Phase 1 study of Acne Vulgaris, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. Androgens have been associated with the development of acne vulgaris. Recently, a topical androgen receptor inhibitor cream (clascoterone) has been FDA-approved for the treatment of acne. However, clinical trials of clascoterone have excluded participants on exogenous hormones. Clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.
Primary Outcome
Total count of papules (including pustules) will be measured on the entire face at screening and monthly during the three month treatment period. Change in total papules count will be used to compare the efficacy of clascoterone 1% cream versus vehicle at time point week 12 versus week 0.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Clascoterone 1% Top Cream
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-07-22 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What NCT05891795 shows while recruiting
NCT05891795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT05891795 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05891795 about?
NCT05891795 is a clinical study titled "Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy". Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they ...
What is the current status of trial NCT05891795?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-07-22. Estimated completion is 2025-12.
What conditions does trial NCT05891795 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT05891795?
The interventions under investigation include: Vehicle (DRUG), Clascoterone 1% Top Cream (DRUG).
Who is sponsoring clinical trial NCT05891795?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05891795 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acne Vulgaris
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05891795's enrollment target sits among peer trials
18 64th of 67 higher than 4 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Lipidome and Microbiome Profile of Acne
ACTIVE NOT RECRUITING · Phase 1
-
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
COMPLETED · Phase 1
-
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
COMPLETED · Phase 1
-
A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
COMPLETED · Phase 1
-
A Study to Evaluate the Potential of Tazarotene Foam to Cause a Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers
COMPLETED · Phase 1
-
A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI