Assessment of Biological, Biometrological Parameters and Consumer Needs in Adult Subjects with Acne (NCT06841393) | Clinical Trial Compass
TerminatedNot Applicable
Assessment of Biological, Biometrological Parameters and Consumer Needs in Adult Subjects with Acne
Stopped: Lack of recruitment
France50 participantsStarted 2023-10-16
Plain-language summary
Acne vulgaris (acne) is a chronic inflammatory pathology of the pilosebaceous unit. Its prevalence is about 85% of teenagers and is constantly increasing in adults, especially women. Acne is a multifactorial disease involving abnormalities in follicular keratinization, sebum production, skin microbiota and inflammation.
The early stage of acne is characterized by the presence of primary retentional lesions: the open comedones (or blackheads) and closed comedones (or whitehead). These retentional lesions can progress to highly inflammatory lesions: superficial inflammatory lesions (papules and pustules) and in some cases in deep inflammatory lesions (nodules). Finally, acne lesions can lead to the development of superficial post inflammatory erythema or hyperpigmentation, resulting in emotional distress and a poorer quality of life.
Currently, a better understanding of the switch from healthy to acne-prone skin, but also of the transition from retentional lesions to more severe inflammatory lesions, seems essential to propose adapted and specific treatments.
The aim of this study is to better understand acne pathophysiology of the face by a multi-omic approaches, biometrological analysis and consumer needs collection to bring information, in the same study on the local ecosystem of non-lesional areas, retentional lesional areas and inflammatory lesional areas of adult acne prone skin, compared to acne free face.
Who can participate
Age range
18 Years – 30 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.
Inlcusion criteria:
Criteria related to the population:
* Subject aged between 18 and 30 years included
* For women of childbearing potential: use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 3 months before inclusion in the study
Criteria related to diseases:
Specific for acne group:
• Subject with acne lesions on the face, with a Global Acne Evaluation (GEA) score evaluated on the face of 2 (mild) or 3 (moderate) assessed by the investigator on a 5-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe)
Non-inclusion criteria:
Criteria related to the population:
* For women of childbearing potential: pregnant or breastfeeding
* Subject having received on face artificial UV exposure, excessive or prolonged exposure to natural sunlight within 4 weeks before the inclusion visit
* Subject with facial hair liable to interfere with the study assessments
Criteria related to the disease:
* Clinical signs of hormone dysfunction or hyperandrogenism
* Severe form of acne (acne conglobata, acne fulminans or nodulocystic acne) or acneiform eruptions, in the investigator's opinion
* Sunburn on the face due to excessive UV exposure
Criteria related to skin condition:
• Subject having any other dermatologic condition than acne, or characteristics (like tattoo) on the face liable to interfere with the study assessments
Specific for control group:
* Subject with significant acne lesions ac…
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
Cutaneous pH measurement
Timeframe: baseline (Visit 1- Day 1)
2
Sebum quantification
Timeframe: baseline (Visit 1- Day 1)
3
Cutaneous barrier integrity
Timeframe: baseline (Visit 1- Day 1)
4
Epigenetic analysis by sampling method (urine)
Timeframe: baseline (Visit 1- Day 1)
5
Microbiota profile by sampling method (swabs)
Timeframe: baseline (Visit 1- Day 1)
6
Microbiota profile by sampling method (extracted comedones)