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

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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation
• Intervention / Treatment: Drug: DBI-102; Drug: Vehicle gel; Drug: Hydroquinone Cream

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• El Salvador
  • La Libertad
    • Santa Tecla, La Libertad, El Salvador, CP1501
      • Zepeda Dermatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Exclusion criteria 5 and 6).
• Unwilling to discontinue applying any prescription or over the counter (OTC) topical product creams and ointments, other than makeup and moisturizers, on treatment area(s) at Baseline through their last day of study.
• Treatment of any type of cancer within 6 months of Screening with the exception of superficial skin cancers such as basal cell or squamous cell carcinoma.
• Known allergy to any of the test article(s) or any components in the test article(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
• History of active atopic dermatitis, as diagnosed by a physician, requiring treatment within the past 2 years.
• Unable to meet the study attendance requirements.
• Any history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
• Participation in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.

Additional Exclusion Criterion for the Sub-Cohort

• Any previous treatment for solar lentigos on the dorsal hands.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBI-102; Topical DBI-102 Gel, 0.8% twice daily for 12 weeks for the randomized cohort	Drug: DBI-102; Topical application on dorsal hand and upper volar arm
Placebo Comparator: Vehicle gel; Inactive comparator	Drug: Vehicle gel; Inactive comparator
Active Comparator: Hydroquinone cream; 4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks	Drug: Hydroquinone Cream; 4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Proportion of subjects with less pigmentation at treated sites vs contralateral untreated sites	At weeks 2,4,6,8,10, and 12

Collaborators and Investigators

• Sponsor: DermBiont, Inc.
• Investigators: Principal Investigator: David Zepeda, MD, Zepeda Dermatologia

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: August 20, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: CT-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No