CompletedNot Applicable

A Clinical Evaluation of Marula-Derived Ceramide Cream on Skin Barrier Function Enhancement

China32 participantsStarted 2025-02-06

Plain-language summary

Previously, the investigators have demonstrated in vitro the excellent efficacy of marula oil-derived ceramide NPs in enhancing skin barrier function. The investigators's findings show that marula oil-derived ceramide NPs not only significantly reduces levels of inflammatory cytokines but also promotes the expression of key proteins in skin barrier integrity. These results suggest that marula oil-derived ceramide NPs may offer a more effective therapeutic option for skin barrier-disrupted diseases. Therefore, the investigators aim to further investigate the repair function of marula oil-derived ceramide NPs on the human epidermal barrier through a clinical trial.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Healthy females aged 18 to 60 years * Skin types: oily, combination oily, neutral, dry, or combination dry * Ethnicity: Asian (Chinese) * Sensitive skin confirmed by lactic acid stinging test screening * Transepidermal water loss (TEWL) \> 15 g/h/m² in one cheek area * Stratum corneum moisture content \<50 C.U. in one cheek area * Visual redness score 3-6 per SGS standard atlas (0-9 scale, 0.5-point increment) * Willingness to sign photo consent form * No significant skin lesions, scars, or excessive facial/neck hair * Ability to comply with protocol requirements and maintain consistent lifestyle Exclusion Criteria Refusal to sign informed consent * Unwillingness to comply with protocol requirements * Concurrent participation in other clinical studies * Cosmetic/drug use on assessment day * Pregnancy or lactation (self-reported) * Pharmacological treatment during study * Infectious skin diseases or atopic dermatitis * Skin abnormalities in assessment area (e.g., moles, telangiectasia) * Skin peeling/cosmetic procedures within 3 months prior to enrollment * Immunosuppressant therapy within 3 months prior to enrollment * Systemic steroid treatment or phototherapy within 1 month prior to enrollment * Use of topical medications/special efficacy cosmetics on target area within 2 weeks prior to enrollment * Assessment area lesions interfering with measurements * History of severe reactions to cosmetics, drugs, or light exposure * Principal Investigator discr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of Transepidermal Water Loss (TEWL) Following Topical Facial Cream Application

Timeframe: Outcome assessments: baseline (Day 0), Day 7, and Day 28 (after 28 days of twice-daily cream application). Total study duration: 28 days.

Evaluation of Skin Hydration Following Application of a Topical Facial Cream

Timeframe: Outcome measures are assessed at baseline (Day 0), Day 7 (7 days after cream initiation), and Day 28 (28 days after cream initiation). Participants apply the cream twice daily throughout the 28-day study period.

Evaluation of Erythema Severity Using a* Color Value in Facial Skin

Timeframe: Measurements at Baseline (Day 0), Day 7, and Day 28 during the 28-day intervention period.

Quantitative Assessment of Facial Erythema Area.

Timeframe: Outcome assessed at Baseline (Day 0), Day 7 , and Day 28 during 28-day study.

Effect of Topical Facial Cream on Skin Thickness.

Timeframe: Assessments at Baseline (Day 0), Day 7 , and Day 28 during 28-day intervention period.

Effect of Topical Facial Cream on Skin Density

Timeframe: Outcome assessed at Baseline (Day 0), Day 7, and Day 28 during 28-day intervention period

Trial details

NCT IDNCT07066150

SponsorShanghai Chicmax Cosmetic Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-06

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