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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical drug called clascoterone to determine its effectiveness for pilonidal disease, a common skin condition in the crease of the buttocks. Participants will apply either the clascoterone cream or a placebo cream to the affected area for three months. The study aims to assess whether the cream reduces disease severity, improves symptoms, and lowers inflammation. Ideal candidates are those diagnosed with pilonidal disease who can adhere to a regular treatment routine. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that clascoterone is likely to be safe for humans?

Research shows that clascoterone cream, applied at a 1% strength, has undergone safety testing in people. Studies found clascoterone to be generally safe for 12 weeks of use. Most participants did not experience serious side effects. Some had mild skin reactions, such as redness or burning, but these were uncommon.

The FDA has also approved clascoterone for treating acne, which supports its safety profile. This approval indicates it has passed thorough safety evaluations for acne. Although pilonidal disease differs, using clascoterone for acne offers some reassurance about its safety.

In summary, current research suggests clascoterone is safe for skin use, with only mild side effects reported in some cases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pilonidal disease?

Clascoterone is unique because it offers a topical approach to treating pilonidal disease, an area where systemic treatments like antibiotics and surgical interventions have been the standard options. Unlike other treatments, Clascoterone works as a topical anti-androgen, directly targeting the hormonal pathways that may contribute to the condition, which is a novel mechanism in this context. Researchers are excited about Clascoterone because it could provide a non-invasive, easy-to-apply solution that might reduce reliance on more invasive procedures, potentially improving patient quality of life with fewer side effects.

What evidence suggests that clascoterone might be an effective treatment for pilonidal disease?

This trial will compare clascoterone cream with a placebo for treating pilonidal disease. Research has shown that clascoterone cream might help with skin conditions. In earlier studies, using clascoterone cream at a 1% concentration successfully treated about 18.4% of cases after 12 weeks. This suggests it could lessen symptoms and severity in similar skin issues. Clascoterone blocks certain hormones that can cause skin problems, potentially reducing inflammation and improving skin health. Although specific data on its use for pilonidal disease is limited, its mechanism offers hope for potential effectiveness. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-2-paranasal-sinus-diseases-4-2024-ddc25

Topical Anti-Androgens for Pilonidal Disease Trial Overview The study tests if clascoterone, applied topically, can reduce severity and symptoms of pilonidal disease compared to a placebo. It's randomized, ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06286397/topical-anti-androgens-in-pilonidal-sinus-disease

Topical Anti-Androgens in Pilonidal Sinus Disease 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32320027/

Efficacy and Safety of Topical Clascoterone Cream, 1%, for ... At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8 ...

4. sigma.larvol.com sigma.larvol.com/product.php?e1=301319&tab=newstrac

Winlevi (clascoterone cream 1%) News Spironolactone at 200 mg showed potential effectiveness in terms of total lesion count reduction. These results suggest that both TC and Spironolactone could be ...

5. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDE2MzI0N1PS0bWEARxMMz1Tc1NTA0tTHUMzSwtzSzMLAxDQUcpLLjEwNTAyMLAwUIoFAO2hFNY-

Save Selected 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7177662/

Efficacy and Safety of Topical Clascoterone Cream, 1%, for ... Results of the studies showed positive efficacy outcomes for clascoterone cream, 1%, compared with vehicle, with statistically significant ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616783/

Clinical Review - Clascoterone (Winlevi) - NCBI Bookshelf - NIH The 2 trials demonstrated that 12 weeks of treatment with clascoterone 1% cream applied twice daily likely results in a clinically important improvement in ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05910450

A Study to Evaluate the Efficacy and Safety of Clascoterone ... The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000MultidisciplineR.pdf

213433Orig1s000 - accessdata.fda.gov Expectations on Safety in the Postmarket Setting. The comprehensive analysis of the safety data for clascoterone cream, 1%, identified no safety.