CompletedPhase 2

Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone on Skin Pigmentation and Lentigos

El Salvador75 participantsStarted 2022-08-18

Plain-language summary

This is a randomized, observer-blinded, vehicle-controlled multi-dose trial that examines the effect of twice daily application of 0.8% DBI-102 Gel, 4% Hydroquinone cream, and Vehicle Gel for 12 weeks in adults with Fitzpatrick Skin Types IV-V and a colorimeter L\* measurement between 57.8 and 46.1.

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: * Male or Female at least 18 years of age. * Must be Fitzpatrick Skin Type IV-V and have an L\* measurement between 57.8 and 46.1, using the Chromometer CM-700. * Ability to understand, agree to, and sign the study informed consent form (ICF). * Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted. * Agree not to change their sun exposure at work, home, or leisure. * Technical ability and willingness to apply test articles. * Willing to allow digital photos of treatment and comparison areas to be taken and stored. Additional Inclusion Criterion for the solar lentigo Sub-Cohort: * At least 4 solar lentigos at least 4 mm in diameter present on each dorsal hand. Exclusion Criteria: * Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study. * Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to, melasma or vitiligo affecting the treatment and comparison sites. * Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal). * Current tanning booth exposure or any kind of phototherapy within 3 months of Screening. * Current or past use of monobenzyl ether or hydroquinone (Ben…

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

Decrease in pigmentation based on melanin index

Timeframe: 12 weeks after first dose

Decrease in pigmentation based on digital imaging

Timeframe: 12 weeks after first dose

Trial details

NCT IDNCT05511948

SponsorDermBiont, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-07

View on ClinicalTrials.gov More Hyperpigmentation trials