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Retinoid

Winlevi (clascoterone) 1% & Adapalene 0.3% gel for Acne

Q: What are the potential risks associated with using Winlevi (clascoterone) 1% & Adapalene 0.3% gel for individuals?

<p>The safety evaluation of Winlevi (clascoterone) 1% &#x26; Adapalene 0.3% gel by the Power team is a level 3 rating due to its Phase 4 trial status, indicating regulatory approval for this treatment.</p>

Phase 4

Waitlist Available

Research Sponsored by Sun Pharmaceutical Industries Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4,8,12,16, 20

Awards & highlights

Study Summary

This trial is looking at using Winlevi, a new acne treatment, along with Adapalene gel to see how well they work together in treating acne. There haven't been any studies on

Who is the study for?

This trial is for individuals with acne vulgaris. Participants should be willing to apply two topical treatments, Clascoterone 1% cream and Adapalene 0.3% gel, as part of their daily skincare routine.Check my eligibility

What is being tested?

The study tests the effectiveness of combining Winlevi (Clascoterone) cream with Adapalene gel in treating acne, which mimics real-life treatment practices.See study design

What are the potential side effects?

Potential side effects may include skin irritation, dryness, redness, burning sensation where the medication is applied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4,8,12,16, 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4,8,12,16, 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4,8,12,16, 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16.

Secondary outcome measures

Assessment of skin oiliness based on 5-point severity scale

Percent of inflammatory lesion reduction at week 16 compared to baseline

Percent of non-inflammatory lesion reduction at week 16 compared to baseline

+6 more

Side effects data

From 2012 Phase 4 trial • 20 Patients • NCT01504204

30%

Dryness

20%

itching

10%

redness

100%

80%

60%

40%

20%

Study treatment Arm

Medication Without Samples

Medication With Sample and Demonstration

Trial Design

1Treatment groups

Experimental Treatment

Group I: Winlevi (clascoterone) 1% & Adapalene 0.3% gelExperimental Treatment1 Intervention

Combined use of Winlevi twice daily and Adapalene once daily

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedLead Sponsor

64 Previous Clinical Trials

13,491 Total Patients Enrolled

1 Trials studying Acne

201 Patients Enrolled for Acne

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently open for this ongoing medical study?

"As per clinicaltrials.gov, this particular research endeavor is not actively seeking participants. Despite being initially posted on November 15th, 2023 and updated most recently on March 27th, 2024, recruitment is currently closed. However, it's worth noting that there are numerous other trials—specifically 37 studies—that are presently open for enrollment."

Answered by AI

What are the potential risks associated with using Winlevi (clascoterone) 1% & Adapalene 0.3% gel for individuals?

"The safety evaluation of Winlevi (clascoterone) 1% & Adapalene 0.3% gel by the Power team is a level 3 rating due to its Phase 4 trial status, indicating regulatory approval for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne

2023. "A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336603.

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