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

NCT05511948 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-10-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • DermBiont, Inc.

    lead INDUSTRY

Principal Investigators

  • David Zepeda, MD · Zepeda Dermatologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2023-03-07
Completion
2023-03-07

Countries

  • El Salvador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05511948 on ClinicalTrials.gov