Clascoterone Cream for Rosacea

Overseen By Kayla N Zafar, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Narrows Institute for Biomedical Research

Disqualifiers: Pregnancy, Investigational study, Skin pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called Clascoterone to determine if it can reduce the size of oil glands in individuals with a type of rosacea, a skin condition that causes redness and pimples. The goal is to see if the cream can improve rosacea symptoms, such as bumps and redness. Individuals diagnosed with this specific type of rosacea, known as papulopustular rosacea, and who use consistent skin and hair products might be suitable candidates for the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using any topical or systemic treatments that could interfere with the study, you might need to stop those. It's best to discuss your specific medications with the trial team.

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

Research has shown that clascoterone cream is generally safe for use. In earlier studies, clascoterone, marketed as WINLEVI, was tested for acne treatment. Participants applied the cream twice daily for up to nine months, and most did not report major side effects. Some experienced mild skin reactions like redness or itching, but these were not serious.

The FDA has already approved clascoterone for acne treatment, indicating its reasonable safety. However, it has not been widely tested for rosacea. As this trial is in the early stages, the main goal is to gather more safety information about using clascoterone for rosacea. ^{1 2 3 4 5}

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

Most treatments for rosacea, like topical antibiotics or azelaic acid, work by reducing inflammation and bacterial presence on the skin. Clascoterone cream is unique because it targets the hormonal aspect of rosacea by blocking androgen receptors in the skin. This new mechanism of action could potentially reduce inflammation and lesions more effectively, offering an alternative for patients who don't respond well to traditional treatments. Researchers are excited about clascoterone because it represents a novel approach to treating rosacea, potentially improving outcomes for those with this challenging condition.

What evidence suggests that Clascoterone cream might be an effective treatment for rosacea?

Research has shown that Clascoterone cream 1% can reduce skin oil and lessen acne. Studies have found that it can shrink oil glands, which are often larger in conditions like acneiform rosacea. Tested for acne treatment, it proves effective and gentle on the skin. While specific results for rosacea are still being collected, Clascoterone's mechanism suggests potential benefits. By blocking hormones in the skin that increase oil production, it might help alleviate rosacea symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Jared Jagdeo, MD MS

Principal Investigator

SUNY Downstate Health Sciences University Department of Dermatology

Are You a Good Fit for This Trial?

This trial is for individuals with a type of skin condition called acneiform rosacea. Participants should have this specific form of rosacea to qualify.

Inclusion Criteria

I have been diagnosed with type 2 rosacea.

Able and willing to provide written and verbal informed consent

I can follow the study rules and attend all visits.

Exclusion Criteria

Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline)

Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study

I do not have skin conditions that could affect test results or need treatment that could interfere.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Clascoterone cream 1% to reduce the size of sebaceous glands

12 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clascoterone

Trial Overview

The trial is testing the effectiveness of a cream called Clascoterone 1% in shrinking sebaceous glands in patients with acneiform rosacea.

How Is the Trial Designed?

Group I: Patients with Acneiform or Papulopustular Rosacea Experimental Treatment 1 Intervention

Patients with diagnosis of papulopustular or acneiform rosacea

Who Is Running the Clinical Trial?

Narrows Institute for Biomedical Research

Lead Sponsor

Trials

5

Recruited

650+

Sun Pharmaceutical Industries Limited

Industry Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Sun Pharma

Collaborator

Published Research Related to This Trial

Clascoterone cream 1% is an effective treatment for acne vulgaris in patients aged 12 and older, with clinical studies showing safety in subjects as young as nine.

While there were instances of elevated blood potassium levels (hyperkalemia) in both clascoterone and vehicle-treated patients, these were not considered adverse events and did not require monitoring, indicating a favorable safety profile for the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Clinically Relevant Risk of Hyperkalemia with Topical Clascoterone Treatment? Del Rosso, J., Stein Gold, L., Squittieri, N., et al.[2023]

Topical clascoterone cream significantly improves treatment success rates in acne vulgaris, with a risk ratio of 2.87, indicating it is much more effective than placebo in achieving treatment goals.

The cream also effectively reduces noninflammatory lesion counts without increasing the risk of serious adverse events, and it is associated with a lower incidence of nasopharyngitis compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: A systematic review and meta-analysis of randomized placebo-controlled trials. Alkhodaidi, ST., Al Hawsawi, KA., Alkhudaidi, IT., et al.[2021]

Clascoterone 1% cream has been shown to significantly reduce both inflammatory and noninflammatory acne lesions in patients aged 12 and older, with a favorable safety profile observed in long-term studies lasting up to 9 months.

As a topical antiandrogen, clascoterone offers an effective alternative to systemic acne treatments, avoiding systemic side effects and making it suitable for patients who cannot use other medications due to contraindications or adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clascoterone: A Novel Topical Androgen Receptor Inhibitor for the Treatment of Acne. Kalabalik-Hoganson, J., Frey, KM., Ozdener-Poyraz, AE., et al.[2021]

Clascoterone cream 1% has been shown to be safe and effective for treating acne vulgaris in patients aged 12 years and older, maintaining its efficacy over a long-term period of up to 12 months, as demonstrated in a study with 600 participants.

The treatment resulted in significant improvements, with nearly 49% of patients achieving clear or almost clear skin by the end of the study, while the incidence of treatment-emergent adverse events was relatively low at 18.1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris. Eichenfield, LF., Hebert, AA., Gold, LS., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06952517

Efficacy and Safety of Topical Clascoterone (WINLEVI) ...

Study Overview. To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.

2.

ncbi.nlm.nih.gov

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

Clinical Review - Clascoterone (Winlevi) - NCBI Bookshelf - NIH

The clinical expert noted that treatment success should be determined at 3 months, apart from treatment with an oral contraceptive and spironolactone, which ...

3.

acneandrosacea.org

acneandrosacea.org/blog/winlevi-suitable-for-use-in-topical-combination-therapy-poster-data/

Winlevi Suitable for Use in Topical Combination Therapy

Winlevi (clascoterone, Sun Pharma) Cream 1% significantly reduces sebum production, reduces acne severity while providing tolerability for patients with skin ...

4.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/603517

Efficacy and Safety of Topical Clascoterone (WINLEVI) ...

To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.

5.

practicaldermatology.com

practicaldermatology.com/topics/acne-rosacea/Impact-Clascoterone-Topical-Cream/32830/

Clascoterone topical cream, 1% (Winlevi), for acne

The safety and efficacy were supported by two successful Phase 3 randomized controlled trials, one open-label long-term safety study, and five ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/psg/PSG_213433.pdf

Clascoterone Topical Cream - accessdata.fda.gov

Subjects who worsen beyond Grade 4 are to be described in the safety evaluation. d. Willing to refrain from use of all other topical acne medications or ...

7.

va.gov

va.gov/formularyadvisor/DOC_PDF/MON_Clascoterone_WINLEVI_Cream_in_Acne_Apr_2022.pdf

Clascoterone (WINLEVI) Cream National Drug Monograph ...

Clascoterone was statistically superior to placebo and numerically (nonsignificantly) better than tretinoin in both total lesion count and acne severity index. ...