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

NCT05511948 | Completed Phase 2

• 1 other identifier: CT-212
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

  At weeks 2,4,6,8,10, and 12

Study Arms (3)

DBI-102

EXPERIMENTAL

Topical DBI-102 Gel, 0.8% twice daily for 12 weeks for the randomized cohort

Drug: DBI-102

Vehicle gel

PLACEBO COMPARATOR

Inactive comparator

Drug: Vehicle gel

Hydroquinone cream

ACTIVE COMPARATOR

4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks

Drug: Hydroquinone Cream

Interventions

DBI-102 DRUG

Topical application on dorsal hand and upper volar arm

DBI-102

Vehicle gel DRUG

Inactive comparator

Vehicle gel

Hydroquinone Cream DRUG

4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks

Hydroquinone cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At least 4 solar lentigos at least 4 mm in diameter present on each dorsal hand.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (1)

Zepeda Dermatologia

Santa Tecla, La Libertad Department, CP1501, El Salvador

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Zepeda, MD

  Zepeda Dermatologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The open label sub-cohort will not have masking.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 3-arm tranche of main cohorts, to be followed by open-label Solar Lentigo sub-cohort

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: August 23, 2022
• Study Start: August 18, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)