EczemaNCT07463079
Clinical Evaluation of a Soothing Moisturizing Lotion in Individuals With Atopic Eczema
A study testing Moisturizing lotion in people with Eczema, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
To investigate the safety and efficacy of the moisturizing lotion in improving eczema symptoms among individuals with atopic eczema in Malaysia. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eczema
- What is being tested?
- Moisturizing lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2026to 30 Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Malaysian women and men
- Age above 18 years old
- Clinically diagnosed with eczema with mild to moderate severity on any parts of the body as evaluated by Eczema Area and Severity Index (EASI) (score 10-20).
Who cannot join
- History of allergies or adverse reactions to moisturizers or components of the specific products being tested
- History of chronic allergies
- Pregnant, breastfeeding women, or those planning pregnancy during the study period
- Participants with documented autoimmune diseases.
- Currently undergoing or requiring active drug treatment for atopic dermatitis or eczema
- Use of any medication (topical or systemic) that could interfere with the study aim (e.g. corticosteroids, calcineurin inhibitors, methotrexate) 3 months prior to the start of the study treatment and throughout the study
- Current participation in another interventional clinical study
- Presence of dermatological or systemic disorder other than eczema that could interfere with study outcomes
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
USMARI Research & Innovation Centre
Petaling Jaya, Selangor, 47810
About this study
To investigate the safety and efficacy of the moisturizing lotion in improving eczema symptoms among individuals with atopic eczema in Malaysia. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4.
The main questions this study aims to answer are:
- To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia.
- To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia.
- To assess the participants' satisfaction after using the moisturizing lotion.
- Conditions
- Eczema
- Being tested
- Moisturizing lotion
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizing lotionOther
Moisturizing lotion containing Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter
| Study group | Role | What they receive |
|---|---|---|
| Moisturizing lotion | Other | The moisturizing lotion contain Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter to be applied adequately by the participants Receives: Other: Moisturizing lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI) score
The Eczema Area and Severity Index (EASI) will be assessed by a dermatologist by evaluating four body regions (head/neck, upper limbs, trunk, and lower limbs), scoring the severity of erythema, edema/papulation, excoriation, and lichenification on a 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), estimating the percentage of skin affected in each region using a 0-6 score corresponding to 0-100% involvement, and calculating a weighted total score ranging from 0 (no eczema) to 72 (most severe eczema).
Measured: baseline, week 4
Investigator's Global Assessment (IGA) score
IGA will be scored by a dermatologist to assess atopic eczema severity using a 6-point scale:
0 = Clear: No inflammatory signs of atopic eczema
- = Almost clear: Just perceptible erythema and just perceptible papulation/infiltration
- = Mild disease: Mild erythema and mild papulation/infiltration
- = Moderate disease: Moderate erythema and moderate papulation/infiltration
- = Severe disease: Severe erythema and severe papulation/infiltration
- = Very severe disease: Severe erythema and severe papulation/infiltration with oozing/crusting
Measured: baseline, week 4
Overall Dry Skin (ODS) score
Visual dryness will be scored by a dermatologist using the Overall Dry Skin (ODS) scale, where 0 indicates no dryness and 4 indicates marked dryness characterized by large scales, pronounced roughness, redness, eczematous changes, or cracks.
Measured: baseline, week 4
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The safety of the moisturizing lotion will be evaluated throughout the study by monitoring adverse events (AEs) reported by participants. The product tolerability will be evaluated using a self-administered questionnaire at week 4. Participants will be asked to rate their level of redness, stinging sensation, tightening, itching, dryness, scaling, and burning on a 6-point scale, with 0 indicating 'none' and 5 indicating 'very severe
Measured: 4 weeks
Participant satisfaction
Participation satisfaction towards product efficacy will be evaluated using a survey. Participants rated their level of agreement with each statement using a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = not sure, 4 = agree, 5 = strongly agree).
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- USMARI Research & Innovation Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463079
- Sponsor's protocol ID
- UMRAMREC005-25
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Soothing Moisturizing Lotion in Individuals With Atopic Eczema
- ClinicalTrials.gov ID
- NCT07463079
- Acronym / sponsor ID
- UMRAMREC005-25
- Conditions
- Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Mar 2026 (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.
To investigate the safety and efficacy of the moisturizing lotion in improving eczema symptoms among individuals with atopic eczema in Malaysia. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4.
The main questions this study aims to answer are:
- To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia.
- To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia.
- To assess the participants' satisfaction after using the moisturizing lotion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moisturizing lotion | Other | Other: Moisturizing lotionThe moisturizing lotion contain Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter to be applied adequately by the participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Malaysian women and men
- Age above 18 years old
- Clinically diagnosed with eczema with mild to moderate severity on any parts of the body as evaluated by Eczema Area and Severity Index (EASI) (score 10-20).
Key exclusion criteria (8 listed)
- History of allergies or adverse reactions to moisturizers or components of the specific products being tested
- History of chronic allergies
- Pregnant, breastfeeding women, or those planning pregnancy during the study period
- Participants with documented autoimmune diseases.
- Currently undergoing or requiring active drug treatment for atopic dermatitis or eczema
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 |
|---|---|---|
| Moisturizing lotionMoisturizing lotion containing Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter | Other | Moisturizing lotion |
Primary outcome
Eczema Area and Severity Index (EASI) score
Time frame: baseline, week 4
The Eczema Area and Severity Index (EASI) will be assessed by a dermatologist by evaluating four body regions (head/neck, upper limbs, trunk, and lower limbs), scoring the severity of erythema, edema/papulation, excoriation, and lichenification on a 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), estimating the percentage of skin affected in each region using a 0-6 score corresponding to 0-100% involvement, and calculating a weighted total score ranging from 0 (no eczema) to 72 (most severe eczema).
Investigator's Global Assessment (IGA) score
Time frame: baseline, week 4
IGA will be scored by a dermatologist to assess atopic eczema severity using a 6-point scale: 0 = Clear: No inflammatory signs of atopic eczema 1. = Almost clear: Just perceptible erythema and just perceptible papulation/infiltration 2. = Mild disease: Mild erythema and mild papulation/infiltration 3. = Moderate disease: Moderate erythema and moderate papulation/infiltration 4. = Severe disease: Severe erythema and severe papulation/infiltration 5. = Very severe disease: Severe erythema and severe papulation/infiltration with oozing/crusting
Overall Dry Skin (ODS) score
Time frame: baseline, week 4
Visual dryness will be scored by a dermatologist using the Overall Dry Skin (ODS) scale, where 0 indicates no dryness and 4 indicates marked dryness characterized by large scales, pronounced roughness, redness, eczematous changes, or cracks.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 4 weeks
Participant satisfaction
Time frame: week 4
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 31 Jul 2026.
- 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 Moisturizing lotion in people with Eczema, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
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 3 inclusion and 8 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 31 Jul 2026. 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 Malaysia. 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?
Eczema Area and Severity Index (EASI) score (time frame: baseline, week 4). The study lists 3 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 31 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.