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

Shanghai Chicmax Cosmetic Co., Ltd.

Status

Completed

Conditions

Xerosis Cutis

Psoriasis

Contact Dermatitis

Atopic Dermatitis (AD)

Acne Vulgaris

Photodamaged Skin

Ichthyosis

Treatments

Other: Apply a cream containing 0.05% marula oil-derived ceramide NPs

Study type

Interventional

Funder types

Industry

Identifiers

NCT07066150

QDCPCH2500065-02-CN

Details and patient eligibility

About

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.

Full description

Marula oil, a botanical ingredient widely utilized in the cosmetics industry, has attracted significant attention due to its exceptional skin-beneficial attributes. Characterized by its richness in monounsaturated fatty acids, predominantly oleic acid, and antioxidants, marula oil exhibits potent moisturizing, anti-inflammatory, anti-aging, and antioxidant activities. Notably, despite sharing a similar fatty acid profile with olive oil, marula oil demonstrates tenfold greater resistance to lipid oxidation. Additionally, the fatty acid chain lengths of marula oil, spanning from C14 to C22, closely align with those of human skin ceramides, positioning it as an ideal precursor for the synthesis of plant-derived ceramide NPs.

Previously, the investigators has demonstrated in vitro that marula oil-derived ceramide NPs have excellent efficacy in enhancing skin barrier function. The investigators' findings show that marula oil-derived ceramide NPs not only significantly reduce levels of inflammatory cytokines but also promote 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.

Against this backdrop, the investigators aims to assess the efficacy of a marula oil-derived ceramide NPs cream in moisturizing, soothing, and repairing the skin barrier. A 28-day prospective study will be conducted on adult subjects, who will use the product as directed under standardized conditions. The investigation will also evaluate the suitability of the cream for sensitive skin, focusing on its non-irritating properties.

Enrollment

32 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 discretion of unsuitability