Clinical Efficacy Evaluation of a Skincare Product for Acne Face, Upper Chest and Back Used by Mu… (NCT06786442) | Clinical Trial Compass
CompletedNot Applicable
Clinical Efficacy Evaluation of a Skincare Product for Acne Face, Upper Chest and Back Used by Multiphototype Population Under Dermatological Control
Brazil130 participantsStarted 2023-11-01
Plain-language summary
The present aims to confirm, under normal conditions of use, the IP's clinical efficacy in controlling acne on the face, upper chest, and back after 28 and 42 days of product use, as well as illustrate its efficacy through standardized pictures. In addition, it is expected to assess the sensations of discomfort reported by participants at cutaneous levels, taking into consideration the product use guidelines determined by the manufacturer, and the self-perceived efficacy by participants immediately after the first application, after 7, 28, 42 days using the IP
Who can participate
Age range
16 Years – 45 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:
All phototypes - with at least 5 subjects of each phototype per assessment area:
* I, II: n=at least 25
* III, IV: n= at least 25
* V, VI: n=at least 25 All skin sensitivity (sensitive or non-sensitive); All skin types (dry, normal, combination or oily); Not presenting severe acne; All ethnicities; At least 75 subjects prone to acne of the face (25 phototypes I-II / 25 phototypes
III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
* Presenting at least 10 retentional lesions on the assessment zone
* Presenting at least 5 inflammatory lesions on the assessment zone
* Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). At least 75 subjects prone to acne of the back (25 phototypes I-II / 25 phototypes
III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
* Presenting at least 10 retentional lesions on the assessment zone
* Presenting at least 5 inflammatory lesions on the assessment zone
* Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). At least 75 subjects prone to acne of the upper chest (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
* Presenting at least 10 retentional lesions on the assessment zone
* Presenting at le…
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
Acne lesion and acne residual brown and red marks count