CClinicalTrials.gg
CompletedNCT07463079Updated Jul 31, 2026

Clinical Evaluation of a Soothing Moisturizing Lotion in Individuals With Atopic Eczema

An interventional study of Moisturizing lotion in Eczema, sponsored by USMARI Research & Innovation Centre. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by USMARI Research & Innovation Centre · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia.
  2. To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia.
  3. To assess the participants' satisfaction after using the moisturizing lotion.
02

Conditions studied

  • Eczema

Browse trials for

03

In context

Eczema

1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 861 interventional studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

USMARI Research & Innovation Centre is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Other
    Moisturizing lotion

    The moisturizing lotion contain Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter to be applied adequately by the participants

    Other: Moisturizing lotion

Interventions

  • OtherMoisturizing lotion

    Moisturizing lotion containing Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline, week 4

  2. 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 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

    Time frame: baseline, week 4

  3. 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.

    Time frame: baseline, week 4

Secondary outcomes

  1. 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

    Time frame: 4 weeks

  2. 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).

    Time frame: week 4

07

Study locations

1 site
  • USMARI Research & Innovation Centre
    Petaling Jaya, Selangor 47810, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07463079
Lead sponsor
USMARI Research & Innovation Centre
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Feb 1, 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Jul 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion