A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Pa… (NCT06415279) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients
United States40 participantsStarted 2024-02-14
Plain-language summary
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. An 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Primary Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study.
. 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.
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):
. 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: