Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentati… (NCT06320314) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
Portugal60 participantsStarted 2024-02-19
Plain-language summary
The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.
Who can participate
Age range
18 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
* only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
* female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study.
Exclusion Criteria:
* female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
* male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
* patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
* severe melasma, dermal melasma
* patient with facial pigmentary disorders other than those described in inclusion criteria
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
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
Timeframe: from baseline to Day84
2
modified Melasma Area and Severity Index (mMASI) for patients with melasma