Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone o… (NCT05511948) | Clinical Trial Compass
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 range18 Years
SexALL
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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…