Trials Sponsors Conditions Drugs Pricing

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
+6 more secondary outcomes

Study Arms (1)

Participation Group/Arm.

OTHER

Experimental: Test cosmetic product Other: Cleanser and sunscreen

Drug: Test cosmetic product

Interventions

Test cosmetic productDrug

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

COD Research
Type not reportedcollaborator
Kayuraeffect, LLP
Industrylead

Study Sites (2)

Delux Health Centre, LLC,

Miami Lakes, Florida, 33014, United States

Pioneer Clinical research

New York, New York, 10016, United States

MeSH Terms

Conditions

HyperpigmentationSkin DiseasesMelanosis

Interventions

Sunscreening Agents

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective AgentsProtective AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesDermatologic Agents

Study Officials

Dr. Prayag Shah, MD, MBA
Intra-group cooperation or coordination
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

January 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.
+7 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Participation Group/Arm.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Participation Group/Arm.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations