ClinicalTrials.gg
Active, not recruitingNCT07780799Updated Aug 24, 2026

Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging

An interventional study of Cosmetic Topical Formulation 1 and Cosmetic Base of Topical Formulation 1 in Aging and Dry Skin, sponsored by L'Oreal. Active, not recruiting at 1 site in China. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by L'Oreal · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Aging
  • Dry Skin
03

In context

Lead sponsor

L'Oreal is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Chinese female subjects aged 35 to 60 years (inclusive) in good general health based on subjective self-report and investigator assessment.
  2. Fitzpatrick skin type II, III, or IV.
  3. Self-reported dry skin type.
  4. 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.
  5. Facial trans-epidermal water loss (TEWL) ≥ 6 g/m²·h as measured by Vapometer.
  6. Facial stratum corneum hydration level between 20 and 45 (inclusive) as measured by Corneometer.
  7. Willing to avoid excessive sun exposure throughout the study period.
  8. Females of (FCBP) must agree to use highly effective methods or remain abstinent from 1 month prior to study start through study completion; or females.
  9. FCBP must have a negative urine pregnancy test at screening.
  10. Willing to undergo tape-stripping procedures for stratum corneum sampling.
  11. No other dermatological conditions deemed unsuitable for participation (e.g., facial tattoos, scars).
  12. Willing to sign Form (ICF) and Image Authorization Form.
  13. Able and willing to comply with all study procedures and visit schedules.

Exclusion criteria

Exclusion Criteria:

  1. Current pregnancy, breastfeeding, or planning to become pregnant.
  2. Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
  3. History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
  4. Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
  5. Known allergies to cosmetics, personal care products, or their ingredients.
  6. Excessive UV exposure or frequent sauna/water sports usage.
  7. Use of antihistamines, antibiotics, , or NSAIDs within relevant .
  8. Participation in any other clinical trial within the past 30 days.
  9. Planned surgical or invasive procedures during the study period.
  10. Individuals deprived of liberty by judicial or administrative order.
  11. Subjects who cannot be reached by telephone in case of an emergency.
  12. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Experimental: 0.05% Active Formulation

    Formulation with 0.05% botanic extract

    Other: Cosmetic Topical Formulation 1

  • Placebo comparator
    Placebo: Vehicle control 1

    Applying the placebo formula without active ingredient

    Other: Cosmetic Base of Topical Formulation 1

  • Experimental
    Experimental: 0.14% Active Formulation

    Formulation with 0.14% botanic extract

    Other: Cosmetic Topical Formulation 2

  • Placebo comparator
    Placebo: Vehicle Control 2

    Applying the placebo formula without active ingredient

    Other: Cosmetic Base of Topical Formulation 2

Interventions

  • OtherCosmetic Topical Formulation 1

    Topical skincare formulation containing Botanical Extract (Concentration 1, 0.05%). Applied topically twice daily for 56 days

  • OtherCosmetic Base of Topical Formulation 1

    Topical skincare formulation base (identical to Active Formulation 1 but without the active botanical extract). Applied topically twice daily for 56 days.

  • OtherCosmetic Topical Formulation 2

    Topical skincare formulation containing Botanical Extract (Concentration 2, 0.14%). Applied topically twice daily for 56 days.

  • OtherCosmetic Base of Topical Formulation 2

    Topical skincare formulation base (identical to Active Formulation 2 but without the active botanical extract). Applied topically twice daily for 56 days.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline, Day 28, Day 56

  2. 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)

    Time frame: Baseline, Day 28, and Day 56

Secondary outcomes

  1. Trans-epidermal water loss(TEWL)

    trans-epidermal water loss using Vapometer (Vapometer, Delfin)

    Time frame: Baseline, Day 28, Day 56

  2. Skin Hydration Index

    Hydration Index using Corneometer(Corneometer CM 825, Courage-Khazaka)

    Time frame: Baseline, Day 28, Day 56

  3. Epidermal Proteomic Profile Changes

    Characterization and untargeted proteomics analysis of epidermal biomarkers obtained via non-invasive tape-stripping (D-Squame) sampling

    Time frame: Baseline and Day 56

07

Study locations

1 site
  • L'OREAL R&I China
    Shanghai, China
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 Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07780799
Lead sponsor
L'Oreal
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Oct 11, 2025
Primary completion
Dec 29, 2025
Completion
Sep 25, 2026 (estimated)
Last update
Aug 24, 2026

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 active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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