Aging ProblemsNCT05160103
16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
A study testing Cosmetic Formulations in people with Aging Problems and Pigmentation, run by Avon Products, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging Problems, Pigmentation
- What is being tested?
- Cosmetic Formulations
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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)
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Aging Problems, Pigmentation
- Being tested
- Cosmetic Formulations
- Keywords
- cosmetic, ethnic skin, anti-aging, pigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic FormulationsOther
Topical emulsions containing anti-aging ingredients
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Every 4 weeks up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single site, randomized, seven treatments, split face, efficacy study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avon Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cape Town, Groote Schuur Hospital
- Responsible party
- Sponsor
- Investigators
- Ardeshir Bayat, PhD, Principal investigator, Professor & Co-Director, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160103
- Sponsor's protocol ID
- 001-2021
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
- ClinicalTrials.gov ID
- NCT05160103
- Acronym / sponsor ID
- 001-2021
- Conditions
- Aging Problems, Pigmentation
- Keywords
- cosmetic, ethnic skin, anti-aging, pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Avon Products, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Cape Town, Groote Schuur Hospital
- Study start
- Jan 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Model description
- Single site, randomized, seven treatments, split face, efficacy study
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic FormulationsTopical emulsions containing anti-aging ingredients | Other | – |
Primary outcome
Skin Tone Unevenness
Time frame: Every 4 weeks up to 16 weeks
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
Skin Firming
Time frame: Every 4 weeks up to 16 weeks
Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek
Skin Moisture
Time frame: Every 4 weeks up to 16 weeks
Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek
Skin Oiliness
Time frame: Every 4 weeks up to 16 weeks
Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ardeshir Bayat, PhD principal investigator
Professor & Co-Director, University of Cape Town
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic Formulations in people with Aging Problems and Pigmentation, run by Avon Products, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Musonda Machona, MD (+27(0)634328862, musondamachona@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Tone Unevenness (time frame: Every 4 weeks up to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.