Impaired BarrierNCT07645339
Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Barrier Repair
A study testing Cosmetic Topical Product A and Cosmetic Topical Product B in people with Impaired Barrier, run by L'Oreal at 1 site in China.
Trial summary
This is a single-center, double-blinded, placebo-controlled, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Impaired Barrier
- What is being tested?
- Cosmetic Topical Product A and Cosmetic Topical Product B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2025to 25 Jul 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 women aged 35 to 60 years in good general health.
- Self-reported dry skin type.
- a hydration index < 35 and a trans-epidermal water loss (TEWL) ≥ 6g.m-2.h-1 on both anterior sides of the forearms at screening.
- Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling.
- Bilateral forearms clear of scars, wounds, or significant pigment spots.
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).
- Allergies to cosmetics, personal care products, or their ingredients.
- Excessive UV exposure or frequent sauna/water sports usage.
- Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within the relevant washout periods.
- Participation in any other clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Double-Blinded, Randomized, Placebo-Controlled, Prospective Study to Evaluate the Efficacy and Safety of a Botanical Extract in Skincare Formulations for Skin Barrier Repair on Healthy Volunteers
This is a single-center, double-blinded, placebo-controlled, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Skin barrier challenge is induced via standardized tape stripping on the volar forearm of healthy subjects. The study will evaluate and compare the repair kinetics of two concentrations of the active formulation, a vehicle, and an untreated control zone over a 14-day application period.
Read the detailed description
Healthy female subjects will undergo a standardized skin barrier challenge (tape-stripping) on designated zones of their volar forearms at baseline. Formulations containing different concentrations of a botanical extract (Active Formulation A and Active Formulation B), a vehicle control, and an untreated control will be assigned to the randomized zones. Products will be applied topically twice daily for 14 days. Skin barrier repair efficacy will be assessed using clinical gradings and instrumental measurements, including Trans-Epidermal Water Loss (TEWL) and skin hydration. Local tolerance will be evaluated via clinical grading. Non-invasive skin surface biomaterial collection may be performed at designated time points for skin proteomics and lipidomics analysis.
- Conditions
- Impaired Barrier
- Being tested
- Cosmetic Topical Product A, Cosmetic Topical Product B, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic Topical Product AOther
Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days.
Cosmetic Topical Product BOther
Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days.
VehicleOther
Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Active Formulation A | Experimental | Zones applying 0.24% active formulation Receives: Other: Cosmetic Topical Product A |
| Active Formulation B | Experimental | Zones applying 0.05% active formulation Receives: Other: Cosmetic Topical Product B |
| Vehicle Control | Placebo comparator | Zones applying the formulation base without active extract Receives: Other: Vehicle |
| Untreated Zone | No intervention | Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales
Measured: Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
Hydration
Hydration index measured using Corneometer
Measured: Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
TEWL
Trans-epidermal water loss using Vapometer
Measured: Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
Secondary outcomes (2)
Skin Structural Changes
Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound
Measured: Baseline, Day 3, Day 7, and Day 14
Epidermal Proteomic and Lipidomic Profile
Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings.
Measured: Baseline, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start13 Oct 2025
- Primary completion3 Nov 2025
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired BarrierStudies 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
- 35 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
- NCT07645339
- Sponsor's protocol ID
- ACR_EV_25-11289
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blinded, Randomized, Placebo-Controlled, Prospective Study to Evaluate the Efficacy and Safety of a Botanical Extract in Skincare Formulations for Skin Barrier Repair on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07645339
- Acronym / sponsor ID
- ACR_EV_25-11289
- Conditions
- Impaired Barrier
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 12 Jun 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, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Skin barrier challenge is induced via standardized tape stripping on the volar forearm of healthy subjects. The study will evaluate and compare the repair kinetics of two concentrations of the active formulation, a vehicle, and an untreated control zone over a 14-day application period.
Detailed description
Healthy female subjects will undergo a standardized skin barrier challenge (tape-stripping) on designated zones of their volar forearms at baseline. Formulations containing different concentrations of a botanical extract (Active Formulation A and Active Formulation B), a vehicle control, and an untreated control will be assigned to the randomized zones. Products will be applied topically twice daily for 14 days. Skin barrier repair efficacy will be assessed using clinical gradings and instrumental measurements, including Trans-Epidermal Water Loss (TEWL) and skin hydration. Local tolerance will be evaluated via clinical grading. Non-invasive skin surface biomaterial collection may be performed at designated time points for skin proteomics and lipidomics analysis.
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 |
|---|---|---|
| Active Formulation A | Experimental | Other: Cosmetic Topical Product AZones applying 0.24% active formulation |
| Active Formulation B | Experimental | Other: Cosmetic Topical Product BZones applying 0.05% active formulation |
| Vehicle Control | Placebo comparator | Other: VehicleZones applying the formulation base without active extract |
| Untreated Zone | No intervention | –Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese women aged 35 to 60 years in good general health.
- Self-reported dry skin type.
- a hydration index < 35 and a trans-epidermal water loss (TEWL) ≥ 6g.m-2.h-1 on both anterior sides of the forearms at screening.
- Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling.
- Bilateral forearms clear of scars, wounds, or significant pigment spots.
Key exclusion criteria (8 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).
- 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 Product ATopical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days. | Other | Active Formulation A |
| Cosmetic Topical Product BTopical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days. | Other | Active Formulation B |
| VehicleTopical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days. | Other | Vehicle Control |
Primary outcome
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
Time frame: Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales
Hydration
Time frame: Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
Hydration index measured using Corneometer
TEWL
Time frame: Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
Trans-epidermal water loss using Vapometer
2 secondary outcomes
Skin Structural Changes
Time frame: Baseline, Day 3, Day 7, and Day 14
Epidermal Proteomic and Lipidomic Profile
Time frame: Baseline, Day 7
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 16 Jun 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 Product A and Cosmetic Topical Product B in people with Impaired Barrier, 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 5 inclusion and 8 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 16 Jun 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?
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH) (time frame: Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14). The study lists 3 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 Jun 2026.