- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06415279
A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients
May 10, 2024 updated by: Sun Pharmaceutical Industries Limited
Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1%
The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes.
If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves.
A newly FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production.
This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval.
This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Dermatology Consulting Services, PLLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Males and females 12+ years of age.
- Subjects with mild to moderate acne.
- Subjects must possess 10-100 total non-inflammatory lesions (open comedones and closed comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 nodules (if deemed appropriate by the PI) on the face.
- Subjects with all Fitzpatrick skin types I-VI.
- Subjects who agree to use only the study products for acne treatment. No other medicated cleansers or moisturizers or acne treatments of any kind are allowed.
- Subjects agree not to introduce any new colored cosmetics or skin care products while participating in the study (lipsticks, eye shadows, facial foundations, blush, powder, cleansers, moisturizers).
- Subjects agree to arrive at all visits with a clean face, having washed his/her face and removed all facial and eye makeup products within 2 hours to 4 hours prior to the visit and is not to use/apply any topical facial product(s) until the visit is completed.
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
- Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
- Subjects in generally good physical and mental health.
- Able to read, write, speak, and understand English
- Individual (and/or his/her legally acceptable representative, as applicable) has signed the Consent for Photograph Release and ICD (and/or Assent Document, as applicable) including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- Subject must avoid sun exposure, or use sunscreen if sun exposure is unavoidable.
- Subject must avoid professional or facial spa procedures during the study.
Exclusion Criteria:
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
- Subjects who are not willing to use the assigned study product to their face as instructed.
- Subjects who have acne nodules/cysts representative of severe acne.
Subjects who are currently using, planning to use during the study or has used any of the following in the specified time range (based on subject report):
- 1 month prior to Visit 1: Prescription (oral or topically applied on the face) antibiotics, inhaled steroids (except those prescribed for allergies), or hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or other medications that could make skin more sensitive or have an effect on the skin, as determined by the PI or designee. Oral contraceptives are acceptable.
- 1 month prior to Visit 1: Prescription medication for acne (e.g. doxycycline, minocycline, clindamycin, sulfamethoxazole and trimethoprim [Bactrim], tetracycline, erythromycin, azithromycin, or Vibramycin®)
- 1 month prior to Visit 1: Topical prescription retinoids (e.g. Retin-A®, Retin-A Micro®, Renova®, Adapalene, Tazarotene, Avita®, Tazorac®, Avage®, Differin®), azelaic acid, benzoyl peroxide, dapsone, sodium sulfacetamide, Epiduo®, or other similar prescription drug on the face
- 6 months prior to Visit 1: Accutane or other oral retinoid
2 weeks prior to Visit 1: Any of the following on the face:
- Light therapy
- OTC topical medications/products (including antiacne or antibacterial agents, topical anti-inflammatories, topical retinoids, etc.). Sunscreens (SPF) are acceptable.
- Females who are pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion. (Subject must document her response in either the source documentation or informed consent/assent forms).
- Subject has a surgery and/or invasive medical procedure planned during the study.
- Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that that could interfere with study evaluations or confound study results, as determined by the PI or designee.
Subject is taking medications that would mask an adverse event (AE) or influence the study results, including:
- Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory drugs within 3 months before Visit 1 and during the study.
- Regular use of antihistamines within 1 month before Visit 1 and during the study.
- Subject has a history of or a concurrent health condition/situation, which in the opinion of the PI, if medically qualified, or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
- Subject is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
- Subjects with clinically significant unstable medical disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects with any known allergies or sensitivities to the study acne products.
- Subjects who are currently under the care of a dermatologist for acne.
- Subjects who are currently experiencing an acne flare.
- Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to the study entry or who plan on starting, stopping or changing doses of HRT or hormones for birth control during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Winlevi (clascoterone) 1% cream
|
Twice daily (BID) dosing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy endpoint is the reduction in causal sebum measurements from the forehead obtained with a sebumeter during the study.
Time Frame: Weeks 16
|
Weeks 16
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary efficacy endpoint is the changes in the facial microbiome induced by 8, 12, and 52 weeks of clascoterone 1% cream application.
Time Frame: Weeks 52
|
Weeks 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 29, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
May 10, 2024
First Submitted That Met QC Criteria
May 10, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 10, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCS-67-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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