Hyperpigmentation
Conditions
Brief 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.
Interventions
DRUGDBI-102
Topical application on dorsal hand and upper volar arm
DRUGVehicle gel
Inactive comparator
4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks
Sponsors
DermBiont, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The open label sub-cohort will not have masking.
Intervention model description
Randomized 3-arm tranche of main cohorts, to be followed by open-label Solar Lentigo sub-cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 (Benoquin) to depigment the skin. * Past or recent use of any skin bleaching treatment within 6 months of Screening. * A chemical peel within 3 months of Screening. * Laser or light-based treatment of the treatment areas within 3 months of Screening. * Use of any photosensitizing medications within the past 6 months of Screening, including psoralens, sulfonamide drugs, tetracycline antibiotics, thiazide diuretics, phenothiazines, coal tar and derivatives, and tricyclic antidepressants. * Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the subject to an unacceptable risk by study participation. * Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in pigmentation based on melanin index | 12 weeks after first dose | Change in L\* and ITA colorimetry measurements |
| Decrease in pigmentation based on digital imaging | 12 weeks after first dose | Change as measured with Canfield RBX software analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Investigator Dynamic Grading Assessment (IDGA) | At weeks 2,4,6,8,10, and 12 | Percent pigmentation differences between treated and contralateral Percent Change in Investigator Dynamic Grading Assessment (IDGA) |
| Proportion of subjects with Improved Investigator Dynamic Grading Scale (IDGA) | At weeks 2,4,6,8,10, and 12 | Proportion of subjects with less pigmentation at treated sites vs contralateral untreated sites |
Countries
El Salvador
Outcome results
None listed