NCT05511948

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

A Randomized, Observer-Blinded, Vehicle-Controlled Study on the Safety and Efficacy of Twice Daily Application of Ruboxistaurin (DBI-102) Gel Vs.Vehicle Gel Vs. Hydroquinone Cream on Sun-Exposed and Sun-Protected Skin of Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperpigmentation

Interventions

Type	Name	Description
DRUG	DBI-102	Topical application on dorsal hand and upper volar arm
DRUG	Vehicle gel	Inactive comparator
DRUG	Hydroquinone Cream	4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks

Timeline

• Start date: 2022-08-18
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2022-08-23
• Last updated: 2023-10-25

Locations

1 site across 1 country: El Salvador