AgingNCT07780799
Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging
A study testing Cosmetic Topical Formulation 1, Cosmetic Base of Topical Formulation 1 and Cosmetic Topical Formulation 2 in people with Aging and Dry Skin, run by L'Oreal at 1 site in China.
Trial summary
This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study to evaluate the anti-ageing efficacy and safety of a topical cosmetic formulation containing a botanical extract. 66 female subjects with dry skin were recruited. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- Cosmetic Topical Formulation 1, Cosmetic Base of Topical Formulation 1 and Cosmetic Topical Formulation 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2025to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese female subjects aged 35 to 60 years (inclusive) in good general health based on subjective self-report and investigator assessment.
- Fitzpatrick skin type II, III, or IV.
- Self-reported dry skin type.
- Meets specified skin criteria assessed by investigator: Crow's feet wrinkle grade between 3 and 5 (inclusive), with priority given to subjects with a side-to-side difference ≤ 0.5 in grade.
- Facial trans-epidermal water loss (TEWL) ≥ 6 g/m²·h as measured by Vapometer.
- Facial stratum corneum hydration level between 20 and 45 (inclusive) as measured by Corneometer.
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- Willing to avoid excessive sun exposure throughout the study period.
- Females of childbearing potential (FCBP) must agree to use highly effective contraception methods or remain abstinent from 1 month prior to study start through study completion; or postmenopausal females.
- FCBP must have a negative urine pregnancy test at screening.
- Willing to undergo tape-stripping procedures for stratum corneum sampling.
- No other dermatological conditions deemed unsuitable for participation (e.g., facial tattoos, scars).
- Willing to sign Informed Consent Form (ICF) and Image Authorization Form.
- Able and willing to comply with all study procedures and visit schedules.
Who cannot join
- Current pregnancy, breastfeeding, or planning to become pregnant.
- Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
- History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
- Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
- Known allergies to cosmetics, personal care products, or their ingredients.
- Excessive UV exposure or frequent sauna/water sports usage.
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- Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within relevant washout periods.
- Participation in any other clinical trial within the past 30 days.
- Planned surgical or invasive procedures during the study period.
- Individuals deprived of liberty by judicial or administrative order.
- Subjects who cannot be reached by telephone in case of an emergency.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Evaluation of a Botanical Extract in Simple Skincare Formulations for Anti-Ageing: A Single Center, Double-Blinded, Placebo-Controlled, Randomized, Split-Face Study
This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study to evaluate the anti-ageing efficacy and safety of a topical cosmetic formulation containing a botanical extract. 66 female subjects with dry skin were recruited. The study compares the anti-ageing benefits of a formula containing the botanical active extract versus a placebo over a 8-week application period.
Read the detailed description
This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study designed to evaluate the anti-ageing efficacy and safety of a botanical extract. 66 subjects with dry skin on both sides of their faces were recruited. A split-face design is utilized in this study. Test products are applied topically twice daily for 56 days.
The primary objective is to assess the skin anti-ageing efficacy (instrumental evaluations including skin tone \& wrinkles, and clinical gradings on signs of ageing) of the active botanical extract compared to a placebo. The secondary objective is to investigate potential mechanisms via untargeted proteomics.
Instrumental evaluations and clinical scorings are performed at Baseline, Day 28, and Day 56. Non-invasive D-Squame tape-stripping samplings for proteomics analysis are collected at Baseline and Day 56.
- Being tested
- Cosmetic Topical Formulation 1, Cosmetic Base of Topical Formulation 1, Cosmetic Topical Formulation 2, Cosmetic Base of Topical Formulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic Topical Formulation 1Other
Topical skincare formulation containing Botanical Extract (Concentration 1, 0.05%). Applied topically twice daily for 56 days
Cosmetic Base of Topical Formulation 1Other
Topical skincare formulation base (identical to Active Formulation 1 but without the active botanical extract). Applied topically twice daily for 56 days.
Cosmetic Topical Formulation 2Other
Topical skincare formulation containing Botanical Extract (Concentration 2, 0.14%). Applied topically twice daily for 56 days.
Cosmetic Base of Topical Formulation 2Other
Topical skincare formulation base (identical to Active Formulation 2 but without the active botanical extract). Applied topically twice daily for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 0.05% Active Formulation | Experimental | Formulation with 0.05% botanic extract Receives: Other: Cosmetic Topical Formulation 1 |
| Placebo: Vehicle control 1 | Placebo comparator | Applying the placebo formula without active ingredient Receives: Other: Cosmetic Base of Topical Formulation 1 |
| Experimental: 0.14% Active Formulation | Experimental | Formulation with 0.14% botanic extract Receives: Other: Cosmetic Topical Formulation 2 |
| Placebo: Vehicle Control 2 | Placebo comparator | Applying the placebo formula without active ingredient Receives: Other: Cosmetic Base of Topical Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles
Evaluation of skin color/tone using Colorimeter (CL400), skin elasticity using Cutometer (MPA 580), and crow's feet wrinkles using PRIMOS CR (Canfield Scientific)
Measured: Baseline, Day 28, Day 56
Clinical Scoring of Facial Ageing Signs
Dermatological grading of crow's feet wrinkles, forehead wrinkles, fine lines on forehead, inter-ocular wrinkles, underneath eye wrinkles, visual smoothness, tactile smoothness, firmness, and skin elasticity using standard clinical visual/tactile grading scales.
crow's feet(0-6, the higher the worse), forehead wrinkles(0-8, the higher the worse), fine lines on the forehead(0-7,the higher the worse), inter-ocular wrinkles(0-7, the higher the worse), underneath eye wrinkles(0-9, the higher the worse),smoothness(Visual)(0-9,the higher the worse), smoothness(tactile)(0-9,the higher the worse), firmness(0-9,the higher the worse), skin elasticity(0-9,the higher the worse)
Measured: Baseline, Day 28, and Day 56
Secondary outcomes (3)
Trans-epidermal water loss(TEWL)
trans-epidermal water loss using Vapometer (Vapometer, Delfin)
Measured: Baseline, Day 28, Day 56
Skin Hydration Index
Hydration Index using Corneometer(Corneometer CM 825, Courage-Khazaka)
Measured: Baseline, Day 28, Day 56
Epidermal Proteomic Profile Changes
Characterization and untargeted proteomics analysis of epidermal biomarkers obtained via non-invasive tape-stripping (D-Squame) sampling
Measured: Baseline and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start11 Oct 2025
- Primary completion29 Dec 2025
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780799
- Sponsor's protocol ID
- ACR_EV_25-11289_01
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 24 Aug 2026
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of a Botanical Extract in Simple Skincare Formulations for Anti-Ageing: A Single Center, Double-Blinded, Placebo-Controlled, Randomized, Split-Face Study
- ClinicalTrials.gov ID
- NCT07780799
- Acronym / sponsor ID
- ACR_EV_25-11289_01
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 24 Aug 2026 (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.
This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study to evaluate the anti-ageing efficacy and safety of a topical cosmetic formulation containing a botanical extract. 66 female subjects with dry skin were recruited. The study compares the anti-ageing benefits of a formula containing the botanical active extract versus a placebo over a 8-week application period.
Detailed description
This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study designed to evaluate the anti-ageing efficacy and safety of a botanical extract. 66 subjects with dry skin on both sides of their faces were recruited. A split-face design is utilized in this study. Test products are applied topically twice daily for 56 days.
The primary objective is to assess the skin anti-ageing efficacy (instrumental evaluations including skin tone \& wrinkles, and clinical gradings on signs of ageing) of the active botanical extract compared to a placebo. The secondary objective is to investigate potential mechanisms via untargeted proteomics.
Instrumental evaluations and clinical scorings are performed at Baseline, Day 28, and Day 56. Non-invasive D-Squame tape-stripping samplings for proteomics analysis are collected at Baseline and Day 56.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: 0.05% Active Formulation | Experimental | Other: Cosmetic Topical Formulation 1Formulation with 0.05% botanic extract |
| Placebo: Vehicle control 1 | Placebo comparator | Other: Cosmetic Base of Topical Formulation 1Applying the placebo formula without active ingredient |
| Experimental: 0.14% Active Formulation | Experimental | Other: Cosmetic Topical Formulation 2Formulation with 0.14% botanic extract |
| Placebo: Vehicle Control 2 | Placebo comparator | Other: Cosmetic Base of Topical Formulation 2Applying the placebo formula without active ingredient |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Chinese female subjects aged 35 to 60 years (inclusive) in good general health based on subjective self-report and investigator assessment.
- Fitzpatrick skin type II, III, or IV.
- Self-reported dry skin type.
- Meets specified skin criteria assessed by investigator: Crow's feet wrinkle grade between 3 and 5 (inclusive), with priority given to subjects with a side-to-side difference ≤ 0.5 in grade.
- Facial trans-epidermal water loss (TEWL) ≥ 6 g/m²·h as measured by Vapometer.
Key exclusion criteria (12 listed)
- Current pregnancy, breastfeeding, or planning to become pregnant.
- Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
- History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
- Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
- Known allergies to cosmetics, personal care products, or their ingredients.
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 Topical Formulation 1Topical skincare formulation containing Botanical Extract (Concentration 1, 0.05%). Applied topically twice daily for 56 days | Other | Experimental: 0.05% Active Formulation |
| Cosmetic Base of Topical Formulation 1Topical skincare formulation base (identical to Active Formulation 1 but without the active botanical extract). Applied topically twice daily for 56 days. | Other | Placebo: Vehicle control 1 |
| Cosmetic Topical Formulation 2Topical skincare formulation containing Botanical Extract (Concentration 2, 0.14%). Applied topically twice daily for 56 days. | Other | Experimental: 0.14% Active Formulation |
| Cosmetic Base of Topical Formulation 2Topical skincare formulation base (identical to Active Formulation 2 but without the active botanical extract). Applied topically twice daily for 56 days. | Other | Placebo: Vehicle Control 2 |
Primary outcome
Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles
Time frame: Baseline, Day 28, Day 56
Evaluation of skin color/tone using Colorimeter (CL400), skin elasticity using Cutometer (MPA 580), and crow's feet wrinkles using PRIMOS CR (Canfield Scientific)
Clinical Scoring of Facial Ageing Signs
Time frame: Baseline, Day 28, and Day 56
Dermatological grading of crow's feet wrinkles, forehead wrinkles, fine lines on forehead, inter-ocular wrinkles, underneath eye wrinkles, visual smoothness, tactile smoothness, firmness, and skin elasticity using standard clinical visual/tactile grading scales. crow's feet(0-6, the higher the worse), forehead wrinkles(0-8, the higher the worse), fine lines on the forehead(0-7,the higher the worse), inter-ocular wrinkles(0-7, the higher the worse), underneath eye wrinkles(0-9, the higher the worse),smoothness(Visual)(0-9,the higher the worse), smoothness(tactile)(0-9,the higher the worse), firmness(0-9,the higher the worse), skin elasticity(0-9,the higher the worse)
3 secondary outcomes
Trans-epidermal water loss(TEWL)
Time frame: Baseline, Day 28, Day 56
Skin Hydration Index
Time frame: Baseline, Day 28, Day 56
Epidermal Proteomic Profile Changes
Time frame: Baseline and Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic Topical Formulation 1, Cosmetic Base of Topical Formulation 1 and Cosmetic Topical Formulation 2 in people with Aging and Dry Skin, run by L'Oreal at 1 site in China.
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 13 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles (time frame: Baseline, Day 28, Day 56). The study lists 2 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 24 Aug 2026.