Topical Anti-Androgens for Pilonidal Disease

Overseen By Lillias Maguire, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Must not be taking: Topical medications

Disqualifiers: Abscess, Pregnancy, Allergic reaction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any topical medication on the affected area during the study.

How does the drug Clascoterone differ from other treatments for pilonidal disease?

Clascoterone is unique because it is a topical anti-androgen, meaning it works by blocking male hormones (androgens) directly on the skin, unlike other treatments that may involve surgery or systemic medications. This localized action helps reduce inflammation and sebum production without the systemic side effects often seen with oral anti-androgens. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are: * Does clascoterone improve the severity of pilonidal disease as scored by a physician? * Does clascoterone improve patient symptoms due to pilonidal disease? * Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey. Researchers will compare participants who received clascoterone treatment to those who received placebo.

Eligibility Criteria

This trial is for individuals with pilonidal disease, a benign skin condition near the tailbone. Participants will use either clascoterone cream or a placebo on the affected area for three months and must be willing to have their treatment progress assessed regularly.

Inclusion Criteria

I can apply creams or ointments as directed.

I have been diagnosed with Pilonidal Disease.

Willingness to comply with study procedures and availability for duration of study

Exclusion Criteria

Treatment with another investigational drug within three months

I am using topical medication on my natal cleft.

I have not had a fever or flu-like illness in the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply clascoterone or placebo cream to the affected area twice daily for 12 weeks with assessment visits at weeks 0, 4, 8, and 12

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of wound complications for those undergoing surgery

8 weeks

Treatment Details

Interventions

• Clascoterone

Trial Overview The study tests if clascoterone, applied topically, can reduce severity and symptoms of pilonidal disease compared to a placebo. It's randomized, meaning participants are randomly assigned to receive either the drug or placebo without choice.

Participant Groups

Group I: Clascoterone Treatment Experimental Treatment 1 Intervention

Participants will apply 1% clasocterone cream to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Group II: Placebo Treatment Placebo Group 1 Intervention

Participants will apply a vehicle cream matched in texture, appearance, and odor to clacoterone to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

Clascoterone is the first topical androgen antagonist approved by the FDA for treating acne, effectively reducing both non-inflammatory and inflammatory acne lesions without systemic side effects.

In Phase III studies, clascoterone demonstrated significant safety and efficacy, making it a promising new option for acne management that targets the underlying hormonal causes of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgens and acne: perspectives on clascoterone, the first topical androgen receptor antagonist. Kircik, LH.[2021]

Clascoterone is a novel topical antiandrogen approved for treating acne, offering a safe and effective alternative to oral antiandrogens, particularly for male patients and certain females who cannot use systemic treatments.

While generally well tolerated, clascoterone can cause localized skin irritation and, in some adolescents, biochemical evidence of HPA suppression, which resolved after stopping the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clascoterone for treatment of acne. Manjaly, C., Martinez, J., Barbieri, J., et al.[2023]

Clascoterone (Winlevi®) is a topical cream approved in the USA for treating acne vulgaris in patients aged 12 and older, acting as an androgen receptor inhibitor to potentially reduce acne-causing signals.

The drug works by competing with dihydrotestosterone for binding to androgen receptors in skin glands, although its exact mechanism for acne treatment is still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clascoterone: First Approval. Dhillon, S.[2022]

Topical clascoterone cream 1% is the first approved topical anti-androgen treatment for acne vulgaris, showing significant effectiveness in two phase III clinical trials involving patients aged 12 and older with moderate-to-severe acne.

Clascoterone works by inhibiting androgen receptors in the skin, specifically targeting the causes of acne without systemic side effects, making it a safer option compared to traditional systemic antiandrogen medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Article: Clascoterone Cream 1%: Mechanism of Action, Efficacy, and Safety of a Novel, First-in-Class Topical Antiandrogen Therapy for Acne. Peterson, H., Kircik, L., Armstrong, AW.[2023]

In a pooled analysis of two phase 3 studies involving 712 patients aged 12 years and older, 1% clascoterone cream significantly improved acne treatment outcomes compared to a vehicle, with 19.9% of patients achieving treatment success versus 7.7% for the vehicle group.

Clascoterone demonstrated a favorable safety profile, with low rates of local skin reactions that were similar to those observed in the vehicle group, indicating it is a safe option for treating moderate-to-severe facial acne vulgaris.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. Hebert, A., Eichenfield, L., Thiboutot, D., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Androgens and acne: perspectives on clascoterone, the first topical androgen receptor antagonist. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

Clascoterone for treatment of acne. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clascoterone: First Approval. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Individual Article: Clascoterone Cream 1%: Mechanism of Action, Efficacy, and Safety of a Novel, First-in-Class Topical Antiandrogen Therapy for Acne. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. [2023]