CClinicalTrials.gg
Status unknownNCT05160103Updated Dec 16, 2021

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

An interventional study of Cosmetic Formulations in Aging Problems and Pigmentation, sponsored by Avon Products, Inc.. Status unknown. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by Avon Products, Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

This is a single site, double-blind randomized, split face, efficacy study. All subjects will receive a cleanser, Day Cream/sunscreen, and two treatment products. The treatment products will be applied in a split face fashion including behind the ear.

Local volunteer subjects will be enrolled such that a total of eighty-four (84) subjects will complete the study; with 24 subjects completing in each treatment.

Each subject will receive a cleanser, Day Cream/sunscreen and two treatment products as per the randomization. Subjects will use the cleanser twice daily, Day Cream/sunscreen in the morning, and the treatment products as specified after cleansing in the evening, for a period of 16 weeks. Clinical assessments, non-invasive instrument measurements and photographs will be completed at baseline and weeks 4, 8, 12, and 16. Biopsies will be taken at baseline and Week 16.

02

Conditions studied

  • Aging Problems
  • Pigmentation

Browse trials for

Keywords

  • cosmetic
  • ethnic skin
  • anti-aging
  • pigmentation
03

In context

Pigmentation Disorders

44 studies on the registry are indexed under Pigmentation Disorders; 11 are open to participants now.

This study's planned enrollment of 84 is above the median of 32 across 33 interventional studies indexed under Pigmentation Disorders.

Browse Pigmentation Disorders studies →

Lead sponsor

This is the only study on the registry with Avon Products, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Be a female in general good health, based on medical history reported by the subject;
  2. From thirty (30) to sixty-five (65) years of age, inclusive;
  3. Fitzpatrick skin types IV, V or VI;
  4. Have mild to moderate skin tone evenness (a score of 3-6);
  5. 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;
  6. Willing to cleanse the face and remove all facial and all eye make-up prior to (or upon arrival) every study visit;
  7. 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;
  8. Willing to refrain from using exfoliating products for the duration of the study;
  9. Not make any changes to her usual skin care regimen while participating in this study, other than those required by the study protocol;
  10. Willing and able to follow all study instructions and adhere to study restrictions;
  11. 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;
  12. 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;
  13. 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)
  • Barrier methods of contraception (condom or diaphragm)
  • Intrauterine device or system (IUD/IUS)
  • Surgical sterilization (vasectomy, hysterectomy, tubal occlusion, uterine ablation)
  • Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence is not an acceptable method of contraception

Exclusion criteria

Exclusion Criteria:

  1. Has participated in any other clinical facial use study within four (4) weeks from the start of the study;
  2. 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;
  3. 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;
  4. Is nursing, pregnant, or planning a pregnancy during the course of this study;
  5. Has excessive facial hair, or scars which could interfere with study evaluation in the opinion of the Investigator;
  6. 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;
  7. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
84 participants (estimated)

Interventions

  • OtherCosmetic Formulations

    Topical emulsions containing anti-aging ingredients

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Every 4 weeks up to 16 weeks

  2. Skin Firming

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

    Time frame: Every 4 weeks up to 16 weeks

  3. Skin Moisture

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

    Time frame: Every 4 weeks up to 16 weeks

  4. Skin Oiliness

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

    Time frame: Every 4 weeks up to 16 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05160103
Lead sponsor
Avon Products, Inc.
Collaborators
University of Cape Town, Groote Schuur Hospital
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Jan 2022 (estimated)
Primary completion
Apr 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Dec 16, 2021

Study contacts

Musonda Machona, MD
Contact
musondamachona@gmail.com
+27(0)634328862
Nonhlanhla P Khumalo, PhD
Contact
n.khumalo@uct.ac.za
+27(0)214043376
Ardeshir Bayat, PhD
principal investigator · Professor & Co-Director, University of Cape Town

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion