Atopic Dermatitis (AD)NCT07066150
A Clinical Evaluation of Marula-Derived Ceramide Cream on Skin Barrier Function Enhancement
A study testing Apply a cream containing 0.05% marula oil-derived ceramide NPs in people with Atopic Dermatitis (AD) and Psoriasis, run by Shanghai Chicmax Cosmetic Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD), Psoriasis, Acne Vulgaris
- What is being tested?
- Apply a cream containing 0.05% marula oil-derived ceramide NPs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2025to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
SGS-CSTC Standards Technical Services (Qingdao) Co., Ltd.
Qingdao, Shandong, 266101
About this study
Official title: Efficacy of Marula Oil-Derived Ceramide Cream in Improving Skin Barrier Function: A Clinical Evaluation
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.
Read the detailed 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.
- Conditions
- Atopic Dermatitis (AD), Psoriasis, Acne Vulgaris, Contact Dermatitis, Photodamaged Skin, Ichthyosis
- Being tested
- Apply a cream containing 0.05% marula oil-derived ceramide NPs
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Acne Vulgaris, Dermatitis, Contact, Ichthyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apply a cream containing 0.05% marula oil-derived ceramide NPsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Marula Oil-Derived Ceramide NPs Cream Treatment Group | Experimental | 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. Receives: Other: Apply a cream containing 0.05% marula oil-derived ceramide NPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Outcome assessed at Baseline (Day 0), Day 7, and Day 28 during 28-day intervention period
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: Self-assessment questionnaires administered at Day 7 and Day 28 post-intervention initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start6 Feb 2025
- Primary completion6 Mar 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chicmax Cosmetic Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066150
- Sponsor's protocol ID
- QDCPCH2500065-02-CN
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Marula Oil-Derived Ceramide Cream in Improving Skin Barrier Function: A Clinical Evaluation
- ClinicalTrials.gov ID
- NCT07066150
- Acronym / sponsor ID
- QDCPCH2500065-02-CN
- Conditions
- Atopic Dermatitis (AD), Psoriasis, Acne Vulgaris, Contact Dermatitis, Photodamaged Skin, Ichthyosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Shanghai Chicmax Cosmetic Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SGS S.A.
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 15 Jul 2025 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marula Oil-Derived Ceramide NPs Cream Treatment Group | Experimental | Other: Apply a cream containing 0.05% marula oil-derived ceramide NPsThe participants were requested to apply a cream containing 0.05% marula oil-derived ceramide NPs on their faces twice daily for 28 consecutive days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Apply a cream containing 0.05% marula oil-derived ceramide NPsThe 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 | Marula Oil-Derived Ceramide NPs Cream Treatment Group |
Primary outcome
Evaluation of Transepidermal Water Loss (TEWL) Following Topical Facial Cream Application
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.
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).
Evaluation of Skin Hydration Following Application of a Topical Facial Cream
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.
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.
Evaluation of Erythema Severity Using a* Color Value in Facial Skin
Time frame: Measurements at Baseline (Day 0), Day 7, and Day 28 during the 28-day intervention period.
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.
Quantitative Assessment of Facial Erythema Area.
Time frame: Outcome assessed at Baseline (Day 0), Day 7 , and Day 28 during 28-day study.
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.
Effect of Topical Facial Cream on Skin Thickness.
Time frame: Assessments at Baseline (Day 0), Day 7 , and Day 28 during 28-day intervention period.
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.
Effect of Topical Facial Cream on Skin Density
Time frame: Outcome assessed at Baseline (Day 0), Day 7, and Day 28 during 28-day intervention period
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.
3 secondary outcomes
Assessment of Stinging Response to Topical Facial Cream Using Lactic Acid Stinging Test
Time frame: Single assessment at Baseline (Day 0)
Participant Self-Assessment of Facial Skin Condition Following Topical Product Application
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.
Time frame: Self-assessment questionnaires administered at Day 7 and Day 28 post-intervention initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- 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 Apply a cream containing 0.05% marula oil-derived ceramide NPs in people with Atopic Dermatitis (AD) and Psoriasis, run by Shanghai Chicmax Cosmetic Co., Ltd. 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 15 Jul 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of Transepidermal Water Loss (TEWL) Following Topical Facial Cream Application (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.). The study lists 6 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 15 Jul 2025.