Health TrialsbyHealthPanel

Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

About this trial

The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);

Male or female, 12 years of age or older;

Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.

Disqualifiers

Subject has greater than two (2) facial nodules;

Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;

Subject has used topical and systemic anti-acne medications or therapies;

Subject has received hormonal therapy for acne treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clascoterone

    Drug

    Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

  • Vehicle cream

    Drug

    Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Treatment groups

692 Participants
are divided into 2 treatment groups
Group A: Clascoterone Cream 1%Experimental treatment 1 intervention
Group B: Vehicle creamPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)

Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.

Time frame
Week 12
2

Change From Baseline in Non-inflammatory Lesion (NIL) Counts

Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.

Time frame
Week 12
3

Change From Baseline in Inflammatory Lesion (IL) Counts

Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.

Time frame
Week 12

Secondary outcomes

1

Change From Baseline in Total Lesion Counts

Absolute change from Baseline in total lesions counts in each treatment group at Week 12.

Time frame
Week 12
2

Percent Change From Baseline in Total Lesion Counts

Percent change from Baseline in total lesions counts in each treatment group at Week 12.

Time frame
Week 12
3

Percent Change From Baseline in Inflammatory Lesion Counts

Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.

Time frame
Week 12
4

Percent Change From Baseline in Non-inflammatory Lesion Counts

Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
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