An interventional study of Apply a cream containing 0.05% marula oil-derived ceramide NPs in Atopic Dermatitis (AD), Psoriasis and Acne Vulgaris, sponsored by Shanghai Chicmax Cosmetic Co., Ltd.. Completed at 1 site in China. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Shanghai Chicmax Cosmetic Co., Ltd. · Not applicable, Interventional, and Other
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 32 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →This is the only study on the registry with Shanghai Chicmax Cosmetic Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Exclusion Criteria Refusal to sign
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants were requested to apply a cream containing 0.05% marula oil-derived ceramide NPs on their faces twice daily for 28 consecutive days.
Other: Apply a cream containing 0.05% marula oil-derived ceramide NPs
The participants were requested to apply a cream containing 0.05% marula oil-derived ceramide NPs on their faces twice daily for 28 consecutive days.
Evaluation of Transepidermal Water Loss (TEWL) Following Topical Facial Cream Application
This study measures transepidermal water loss (TEWL) using a Tewameter (Tewameter® TM Hex) device. TEWL measurements are obtained from the standardized cheek area (left and right sides) at baseline (Day 0), 7 days after initiating twice-daily application of the topical facial cream (Day 7), and 28 days after initiation (Day 28). The primary outcome is the TEWL rate, quantified as grams per hour per square meter (g/h/m²).
Time frame: 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
This clinical study evaluates stratum corneum hydration in adult participants using a Corneometer® CM 825 device. Standardized measurements of the designated cheek area (either left or right side, consistently applied for all participants) are performed to assess the primary parameter: stratum corneum moisture content, which is reported in Corneometer Units (C.U.). The study follows a structured protocol where the topical facial cream is applied twice daily as the investigational intervention, aiming to characterize its impact on skin hydration over the study period.
Time frame: 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
This clinical study quantifies facial erythema severity in adult participants by analyzing the CIELAB a\* color value derived from VISIA CR 5.0 - captured images. The target assessment area is a standardized unilateral cheek region (consistently left or right as per pre - defined protocol). Measurements follow a structured protocol, with the primary outcome defined as the change in a\* color value over time, which directly reflects erythema intensity modulation. All image acquisitions and a\* value extractions adhere to validated VISIA CR 5.0 operating procedures to ensure data reliability.
Time frame: Measurements at Baseline (Day 0), Day 7, and Day 28 during the 28-day intervention period.
Quantitative Assessment of Facial Erythema Area.
This clinical study quantitatively assesses facial erythema area in adult participants using the VISIA CR 5.0 system's erythema analysis module. Erythema area percentage (%) is measured at a pre - defined standardized unilateral cheek region (consistently left or right, per protocol). Assessments follow the device's standard erythema detection mode under controlled, validated lighting conditions. The primary outcome is the change in erythema area percentage over the study period, with all measurements adhering to VISIA CR 5.0's validated operating procedures to ensure data reliability.
Time frame: Outcome assessed at Baseline (Day 0), Day 7 , and Day 28 during 28-day study.
Effect of Topical Facial Cream on Skin Thickness.
This clinical study evaluates the effect of a topical facial cream on skin thickness in adult participants. Using the Dermalab® Combo device, standardized measurements of epidermal and dermal thickness (μm) are performed at the zygomatic fat region of a pre - defined unilateral cheek (consistently left or right, per protocol). The primary outcomes are changes in epidermal thickness and dermal thickness over the study period, with all assessments following validated Dermalab® Combo operating procedures to ensure data reliability. The topical facial cream is applied as per the study protocol, and measurements adhere to a structured schedule to characterize its impact on skin thickness.
Time frame: Assessments at Baseline (Day 0), Day 7 , and Day 28 during 28-day intervention period.
Effect of Topical Facial Cream on Skin Density
This clinical study evaluates the effect of a topical facial cream on facial skin density in adult participants. Using the Dermalab® Combo device, standardized measurements of skin density are performed at the zygomatic fat region of a pre-defined unilateral cheek (consistently left or right, per protocol). Skin density is quantified in device-specific arbitrary units, with all assessments following validated Dermalab® Combo operating procedures to ensure data reliability. The primary outcome is the change in skin density over the study period, with the topical facial cream applied as per the study protocol. Measurements adhere to a structured schedule to characterize the cream's impact on skin density.
Time frame: Outcome assessed at Baseline (Day 0), Day 7, and Day 28 during 28-day intervention period
Assessment of Stinging Response to Topical Facial Cream Using Lactic Acid Stinging Test
This study evaluates cutaneous stinging response through a standardized Lactic Acid Stinging Test. Participants receive 10% lactic acid versus distilled water (control) applications on bilateral nasolabial folds. Stinging intensity is scored as: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). Primary outcome: total score summation from both application sites.
Time frame: Single assessment at Baseline (Day 0)
Participant Self-Assessment of Facial Skin Condition Following Topical Product Application
Participants assess facial skin condition using a validated self-assessment questionnaire. Assessment area: Full face. Scoring scale: 0 (ideal skin) to 9 (very unsatisfactory condition).
Time frame: Self-assessment questionnaires administered at Baseline (Day 0), Day 7, and Day 28 during 28-day intervention
Participant-Reported Satisfaction with Topical Facial Product Efficacy.
Participants report satisfaction and perceived efficacy using a self-assessment questionnaire applied to full facial skin. Scale anchors: 1 (very dissatisfied) to 7 (very satisfied).
Time frame: Self-assessment questionnaires administered at Day 7 and Day 28 post-intervention initiation.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.