Stanford University
Stanford, California, 94305, United States
NCT Number: NCT05891795
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.
This study is active but is not currently recruiting participants.
Notify Me16 year and older
All sexes
Interventional
Phase 1 / Phase 2
Stanford, California, 94305, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apply a thin layer to the affected area twice daily.
Apply a thin layer to the affected area twice daily.
Time frame: Week 0, and week 12
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.
Time frame: Week 0, and week 12
Serum testosterone will be measured before starting the treatment (week 0) and following the 3-month course (week 12). We will use the change in serum testosterone to investigate if clascoterone, a local androgen receptor inhibitor, has systemic effects for transgender patients on MHT.
Time frame: Week 0, and week 12
Sebum output will be measured using a Sebumeter SM815 probe (Courage & Khazaka, Köln or Cologne, Germany) before starting the treatment (week 0) and following the 3-month course (week 12). The specifications for the Sebumeter are as follows: Infrared 950 nanometers LED light, Type LED SFH 420 IR 950 nanometers, 1.8 voltz, 50 mAmps, CHIP-SMD. This specific apparatus has been used in several previous acne vulgaris studies. The patient will be asked to not use any topical preparations on their face 24 hours prior to these appointments. Measurements will be taken from the forehead.
Time frame: Week 0, and week 12
Patient reported outcomes will be measured using Acne-QoL and AI-ADL (only for participants 18+ years old) before starting the treatment (week 0) and following the 3-month course (week 12).
Time frame: Week 0, and week 12
Skin microbiome samples will be taken from the nose using noninvasive bacterial swab following the instructions of the manufacturer before starting the treatment (week 0) and following the 3 month course (week 12). Sample preparation and subsequent shotgun sequencing on microbiome samples will be done commercially (Microbiome Insights). Shotgun metagenomic sequencing will be performed using Illumina 2x150 paired-end reads with a mean read depth of at least 6-7 million sequences per sample. High quality reads will undergo taxonomic profiling to obtain relative abundances. Change in relative species percentage & abundance will be used as a correlate for treated versus placebo, responders versus non-responders.
Stanford University
Other
Topical Androgen Receptor Inhibitor for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
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