ANTIPIGMENTING OR DEPIMENTING EFFICACY UNDER PART OF VISIBLE LIGHT (NCT06945393) | Clinical Trial Compass
CompletedNot Applicable
ANTIPIGMENTING OR DEPIMENTING EFFICACY UNDER PART OF VISIBLE LIGHT
Romania30 participantsStarted 2021-10-21
Plain-language summary
The study intends to validate a protocol and define a positive reference to evaluate the efficacy of anti-pigmenting and depigmenting agents under part of visible Light exposures, between 400nm to 450nm.
It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.
Who can participate
Age range
18 Years – 50 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
. Healthy female or male volunteer from 18 to 50 years old
. Skin type III-IV according to the Fitzpatrick classification
. Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 32° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
. Uniform skin color over the eight zones (difference in ITA° between each zone should not be more than 4°)
. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
. Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
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.
. Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
. Subject willing and able to fulfil the study requirements and schedule
Exclusion criteria
. Subject who is pregnant or lactating or who is planning to become pregnant during the study
. Subject with BMI \> 30
. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
. Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion
. Having sunburn (erythema) on the back
. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems