UnknownNot Applicable

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

84 participantsStarted 2022-01

Plain-language 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.

Who can participate

Age range30 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.

What they're measuring

Skin Tone Unevenness

Timeframe: Every 4 weeks up to 16 weeks

Skin Firming

Timeframe: Every 4 weeks up to 16 weeks

Skin Moisture

Timeframe: Every 4 weeks up to 16 weeks

Skin Oiliness

Timeframe: Every 4 weeks up to 16 weeks

Trial details

NCT IDNCT05160103

SponsorAvon Products, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04

Contact for this trial

Musonda Machona, MD

+27(0)634328862 musondamachona@gmail.com

View on ClinicalTrials.gov More Aging Problems trials

Who can participate

Age range30 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.