Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne (NCT02575950) | Clinical Trial Compass
CompletedPhase 2
Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
United States59 participantsStarted 2016-06
Plain-language summary
An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled, double-blinded, split-pace (left/right) design trial to evaluate the efficacy and tolerability of LEO 43204 in adults with moderate to severe acne.
Who can participate
Age range
18 Years – 35 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:
* Subjects should be diagnosed with acne vulgaris of the face
* Fitzpatrick skin types I-III (due to lack of safety data for the investigational product in darker skin types)
* Disease severity and total lesion count should be similar in both TAs
* Disease severity grade as moderate to severe according to the investigator's global assessment (grade 3-4)
* Age 18 to 35 years incl.
* Male or female
* Female Subjects must be of either non-childbearing potential or child-bearing potential with a confirmed negative pregnancy test
Exclusion Criteria:
* Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g. chlor-acne, drug-induced acne)
* Subjects with previous history of keloid formation or post-inflammatory hyperpigmentation
* Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1
* Topical retinoids within 3 months before Day 1 or other topical treatments and/or medicated products and cosmetics that in the opinion of the investigator may influence the subjects acne vulgaris (including soaps containing antibacterial agents such as benzoyl peroxide, keratinolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) within 1 month before Day 1
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
Total Lesion Count (Inflammatory and Non-inflammatory)