Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Barrier Repair
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Shanghai, Kina
- L'OREAL
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Active Formulation A
Zones applying 0.24% active formulation |
Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days. |
|
Experimentell: Active Formulation B
Zones applying 0.05% active formulation |
Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days. |
|
Placebo-jämförare: Vehicle Control
Zones applying the formulation base without active extract |
Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days. |
|
Inget ingripande: Untreated Zone
Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
Tidsram: 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 |
Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
|
Hydration
Tidsram: 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 |
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
Tidsram: 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 |
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin Structural Changes
Tidsram: Baseline, Day 3, Day 7, and Day 14
|
Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound |
Baseline, Day 3, Day 7, and Day 14
|
|
Epidermal Proteomic and Lipidomic Profile
Tidsram: Baseline, Day 7
|
Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings. |
Baseline, Day 7
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ACR_EV_25-11289
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .