16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects

NCT05160103 | Unknown

• 1 other identifier: 001-2021
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the efficacy of seven different formulations currently marketed and commercially available cosmetic products on skin tone evenness, post-inflammatory hyperpigmentation, and discrete pigmentation in females of Fitzpatrick skin types IV-VI.

Conditions

Aging Problems; Pigmentation

Keywords

cosmetic; ethnic skin; anti-aging; pigmentation

Outcome Measures

Primary Outcomes (4)

• Skin Tone Unevenness

  Using a 0-9 scale where 0= even tone and 9=severe blotchy hyperpigmentation. Subjects will be recruited with mild to moderate skin tone unevenness. The goal is to show improvements by dermatologist assessments and photography

  Every 4 weeks up to 16 weeks

• Skin Firming

  Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek

  Every 4 weeks up to 16 weeks

• Skin Moisture

  Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek

  Every 4 weeks up to 16 weeks

• Skin Oiliness

  Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek

  Every 4 weeks up to 16 weeks

Interventions

Cosmetic Formulations OTHER

Topical emulsions containing anti-aging ingredients

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Self-identifying females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a female in general good health, based on medical history reported by the subject;
• From thirty (30) to sixty-five (65) years of age, inclusive;
• Fitzpatrick skin types IV, V or VI;
• Have mild to moderate skin tone evenness (a score of 3-6);
• Willing to avoid excessive solar or UV exposure including: minimizing direct sun exposure and avoiding tanning beds and sunless tanning products for the duration of the study;
• Willing to cleanse the face and remove all facial and all eye make-up prior to (or upon arrival) every study visit;
• Willing to use no other topical products on the face for the duration of the study except the assigned test product and the subject's regular brand(s) of non-medicated make-up products that do not contain salicylic acid, benzoyl peroxide, AHA's, retinol, or their analogs or derivatives;
• Willing to refrain from using exfoliating products for the duration of the study;
• Not make any changes to her usual skin care regimen while participating in this study, other than those required by the study protocol;
• Willing and able to follow all study instructions and adhere to study restrictions;
• Read and sign an IRB approved informed consent form after the nature of the study has been fully explained and all questions have been answered by site staff;
• Female subjects determined to be of child-bearing potential must indicate that they are not pregnant and/or lactating, nor do they intend to become pregnant during their study participation;
• Female subjects determined to be of child-bearing potential must agree to practice a medically acceptable form of birth control during the study;
• Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
• Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring)

You may not qualify if:

• Has participated in any other clinical facial use study within four (4) weeks from the start of the study;
• Has received any type of skin treatment or procedure in the past 3 (3) months including: chemical peels, microdermabrasion, injection of collagen or other filler, Botox® injections, or any treatment involving heat, light, or RF energy;
• Is currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
• Is nursing, pregnant, or planning a pregnancy during the course of this study;
• Has excessive facial hair, or scars which could interfere with study evaluation in the opinion of the Investigator;
• Is taking any prescription or over-the-counter medication that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
• Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.

Sponsors & Collaborators

• Avon Products, Inc.: lead
• University of Cape Town, Groote Schuur Hospital: collaborator

Study Officials

• Ardeshir Bayat, PhD

  Professor & Co-Director, University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Musonda Machona, MD

CONTACT

+27(0)634328862; musondamachona@gmail.com

Nonhlanhla P Khumalo, PhD

CONTACT

+27(0)214043376; n.khumalo@uct.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Products Codes A-G
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single site, randomized, seven treatments, split face, efficacy study

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 16, 2021
• Study Start: January 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share