Efficacy and Tolerability Evaluation of a Novel Dermo-cosmetic Product for Mild-to-moderate Acne (NCT07759505) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Tolerability Evaluation of a Novel Dermo-cosmetic Product for Mild-to-moderate Acne
Romania90 participantsStarted 2022-09-23
Plain-language summary
The goal of this non-interventional, observational study is to evaluate the real-world efficacy and tolerance of a novel dermocosmetic cream containing 15% Azelaic acid and a complex of active ingredients (α-AZ cream) in patients with mild-to-moderate acne treated in routine clinical practice.
The main questions addressed are:
* Does the product show good clinical efficacy on acne and inflammatory lesions in standard practice?
* Does the product offer good cutaneous tolerance during routine use?
Patients are observed across three routine care cohorts according to their prescribed/recommended regimen: α-AZ cream alone (Group 1), α-AZ cream combined with an oral acne treatment (Group 2), or a topical acne treatment (Group 3), over a period of 84 days. The study observes and compares real-world outcomes and tolerance across these standard care management approaches without imposing any protocol-driven treatment allocation.
Researchers will compare the new dermocosmetic cream with group 2 and group 3 to see if the study product shows an equivalent or a better tolerance/efficiency than the drug treatment.
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:
* Sex: female and/or male
* Subject having given his/her informed written consent or parental authorization
* Subject willing to adhere to the protocol and study procedures
* Healthy subject with acne-prone skin: grade 2 or 3 (Global Acne Evaluation \[GEA\] scale).
Exclusion Criteria:
* Excluding treatment:
* Epiduo® or combination of benzoyl peroxide (BPO) + Adapalene
* Oral isotretinoin
* Chronically used anti-inflammatory drugs
* Subject manipulating his/her acneic lesions
* Any change in hormonal treatment (including contraceptives) during the three previous months of the study
* Cutaneous pathology on the study zone (eczema, etc)
* Excessive exposure to sunlight or UV rays within the previous month
* Subject enrolled in another clinical trial during the study period
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
Percentage change from baseline in acne severity total lesion score
Timeframe: Baseline, Day 42, Day 84, and Day 112
2
Percentage change from baseline in Post-Inflammatory Hyperpigmentation (PIH) score