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

Trial Summary

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 clascoterone cream safe for use in humans?

Clascoterone cream has been tested in clinical trials for acne treatment in patients 12 years and older, showing a safety profile similar to placebo with common mild skin reactions like redness and dryness. There were no serious adverse events reported, and while some cases of high blood potassium levels were noted, they were not considered clinically significant. ^{1 2 3 4 5}

How does the drug Clascoterone Cream differ from other rosacea treatments?

Clascoterone Cream is unique because it is a topical anti-androgen treatment, which means it works by blocking the effects of male hormones on the skin, potentially reducing inflammation and lesions associated with rosacea. This mechanism is different from other common treatments like antibiotics or anti-inflammatory creams. ^{6 7 8 9 10}

What is the purpose of this trial?

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

Research Team

Jared Jagdeo, MD MS

Principal Investigator

SUNY Downstate Health Sciences University Department of Dermatology

Eligibility Criteria

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

Able and willing to provide written and verbal informed consent

I have been diagnosed with type 2 rosacea.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

References

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

Clascoterone cream (1%) topical androgen receptor inhibitor for the treatment of acne in patients 12 years and older. [2022]

2. United States 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. [2021]

3. United States 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. [2023]

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

Is There a Clinically Relevant Risk of Hyperkalemia with Topical Clascoterone Treatment? [2023]

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

Clascoterone: A Novel Topical Androgen Receptor Inhibitor for the Treatment of Acne. [2021]

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

Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Cyproterone therapy of papulopustular rosacea in women]. [2013]

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

Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea [2019]

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

Clinical and noninvasive instrumental evaluation of the efficacy of a nonsteroidal anti-inflammatory 8-beta glycyrrhetinic acid cream for the treatment of erythema in rosacea. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Adverse effect of topical fluorinated corticosteroids in rosacea. [2019]