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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBI-102 | Experimental | Topical DBI-102 Gel, 0.8% twice daily for 12 weeks for the randomized cohort |
|
| Vehicle gel | Placebo Comparator | Inactive comparator |
|
| Hydroquinone cream | Active Comparator | 4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBI-102 | Drug | Topical application on dorsal hand and upper volar arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in pigmentation based on melanin index | Change in L* and ITA colorimetry measurements | 12 weeks after first dose |
| Decrease in pigmentation based on digital imaging | Change as measured with Canfield RBX software analysis | 12 weeks after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Investigator Dynamic Grading Assessment (IDGA) | Percent pigmentation differences between treated and contralateral Percent Change in Investigator Dynamic Grading Assessment (IDGA) | At weeks 2,4,6,8,10, and 12 |
| Proportion of subjects with Improved Investigator Dynamic Grading Scale (IDGA) |
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Inclusion Criteria:
Additional Inclusion Criterion for the solar lentigo Sub-Cohort:
Exclusion Criteria:
Additional Exclusion Criterion for the Sub-Cohort
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| Name | Affiliation | Role |
|---|---|---|
| David Zepeda, MD | Zepeda Dermatologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zepeda Dermatologia | Santa Tecla | La Libertad Department | CP1501 | El Salvador |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Randomized 3-arm tranche of main cohorts, to be followed by open-label Solar Lentigo sub-cohort
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The open label sub-cohort will not have masking.
| Vehicle gel |
| Drug |
Inactive comparator |
|
| Hydroquinone Cream | Drug | 4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks |
|
Proportion of subjects with less pigmentation at treated sites vs contralateral untreated sites |
| At weeks 2,4,6,8,10, and 12 |