Open-label, Single-arm, Proof of Concept Study in Subjects with Mild-to-moderate Facial Hyperpigmentation

NCT06473974 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: COD-24-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This research study will test how well hyperpigmentation treatment works for subjects with mild-to-moderate facial hyperpigmentation. The study will also test if the hyperpigmentation treatment causes any irritation. For 12 weeks of the study, participants will use the assigned treatment, along with a provided cleanser and sunscreen.

Conditions

Facial Hyperpigmentation

Keywords

Hyperpigmentation, skin disease, melasma, wrinkles

Outcome Measures

Primary Outcomes (1)

• Overall hyperpigmentation score using modified Griffiths 10-point scale.

  Investigator will evaluate the face of each subject for overall hyperpigmentation using a modified Griffith's 10-point scale at all visits. The score range from 0 to 9 where, 0=none; 1-3=mild; 4-6=moderate; and 7-9=severe. Change from baseline will be calculated, a negative change from baseline show improvement.

  Baseline to week 12.

Secondary Outcomes (11)

• Overall hyperpigmentation score using modified Griffith's 10-point scale.

  Baseline to week 2, 4 & 8

• Number of participant by response for self-assessment questionnaire: Overall improvement in skin condition.

  At week 2, 4, 8 and 12

• Number of participant by response for self-assessment questionnaire: Overall satisfaction with test product.

  At week 2, 4, 8 and 12

• Investigator global assessment for overall hyperpigmentation.

  Baseline to week 2, 4, 8 and 12

• Investigator global assessment for photodamage scores.

  Baseline to week 2, 4, 8 and 12

Study Arms (1)

Participation Group/Arm.

OTHER

Experimental: Test cosmetic product Other: Cleanser and sunscreen

Drug: Test cosmetic product

Interventions

Test cosmetic product DRUG

Test cosmetic product: Test cosmetic product will be applied to affected hyperpigmented areas twice daily at AM and PM. Cleanser and sunscreen: A facial cleanser will be used twice daily (morning and evening) by gently rubbing it on face and neck, then rinse and pat dry. Sunscreen of SPF 50, apply evenly on face and neck, 20 minutes before stepping out.

Also known as: Cleanser and Sunscreen

Participation Group/Arm.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
• Female or male aged 18-60 years (both inclusive), with Fitzpatrick skin types I-VI.
• Subjects with mild-to-moderate facial hyperpigmentation (including but not limited to melasma, PIH, solar lentigines, or dark spots, etc.) based on modified Griffiths 10-point scale.
• Note:
• Affected areas include the forehead, cheeks (malar), nose, perioral area, and chin.
• Men who shaved regularly (at least three times weekly) with no beards will be allowed to participate.
• Subjects of all races and ethnicities including, but not limited to, Caucasian, African-American, Latino, Asian, Middle Eastern and East Indian will be enrolled for the present study.
• Subjects willing to sign have their photographs taken during the study and willing to sign a photography release.
• Willing to withhold all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
• Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
• Subjects willing to use cosmetic product regimen on their face provided by the sponsor (e.g. Cleanser, and Sunscreen).
• Willingness to not begin using any new cosmetic facial make-up during the study. If regular users of cosmetic facial make-up, they must have used the products without any tolerability issues for at least 2 weeks prior to starting the study.
• Willingness to avoid facial makeup tattoos including but not limited to eyebrows, eye line, lips or lash extensions during the 12-week study.
• Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Subjects will be instructed to wear protective clothing prior to and during exposure. Any extended sun exposure must be recorded in the source documents.
• Male subjects (including vasectomized) with partners who are of childbearing potential (whether pregnant or not) must use condoms prior to first IP application and until 7 days after last IP application. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above mentioned duration.

You may not qualify if:

• Unwilling or unable to comply with scheduled visits, cosmetic product application plan, laboratory tests, or other study procedures and study restrictions.
• Subjects diagnosed with known allergies to study provided skin care products.
• Subjects who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
• Subjects with a history of skin cancer.
• Subjects having a health condition and/or pre-existing or dormant dermatologic disease on the face/planned treatment area (e.g. psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriation) that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
• Subjects with facial plastic surgery or ablative laser resurfacing during the past year; non-ablative laser resurfacing, neurotoxins, or dermal fillers during the previous 3 months; superficial resurfacing treatment (chemical peels, microdermabrasion, micro-needling), neurotoxin or dermal fillers during the previous 6 weeks.
• Subjects with a history of immunosuppression/immune deficiency disorders \[including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g. azathioprine, belimumab, cyclophosphamide, etanercept, adalimumab, mycophenolate mofetil, methotrexate, prednisone, infliximab, ustekinumab) and/or radiation as determined by study documentation that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
• Subjects with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Subjects having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medications, etc.
• Subjects who have observable suntan, scars, nevi, excessive hair, etc., or other dermal conditions on the face that might influence the test results in the opinion of the investigator or designee.
• Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
• Individuals who used any of the following medications or had any of the listed procedures within the listed time frame prior to the study start date:
• i. Tretinoin, Tazarotene, or Adapalene within 3 months. ii. Had a light-depth chemical peel, medium-depth microdermabrasion, any systemic steroids, non-ablative laser, light and/or ratio frequency or fractional laser resurfacing of the face and neck within 01 month.
• iii. Any systemic retinoid (e.g. Acitretin, Isotretinoin) within 5 half-lives of its last dose.
• iv. Oral Tranexamic acid or topical applications containing depigmenting agents within 5 half-lives of its last dose.
• v. Any topical or systemic antibiotics, such as minocycline, or any other known medications that can cause photosynthesis, such as hydrochlorothiazide, furosemide, amiodarone, within 5 half-lives of its last dose.

Sponsors & Collaborators

• Kayuraeffect, LLP: lead
• COD Research: collaborator

Study Sites (2)

Delux Health Centre, LLC,

Miami Lakes, Florida, 33014, United States

Location

Pioneer Clinical research

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hyperpigmentation; Skin Diseases; Melanosis

Interventions

Sunscreening Agents

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Dr. Prayag Shah, MD, MBA

  Intra-group cooperation or coordination

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, Safety and Efficacy

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: January 1, 2025
• Primary Completion: May 10, 2025
• Study Completion: December 15, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)