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

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.

Study Overview

• Status: Recruiting
• Conditions: Eczema
• Intervention / Treatment: Other: Moisturizing lotion

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 47810
      • Recruiting
      • USMARI Research & Innovation Centre
      • Contact: Siti Nur Hanis Mamood, PhD; Phone Number: +60167572670; Email: hanis@usmari.org.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Moisturizing lotion containing Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	baseline, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	week 4

Collaborators and Investigators

• Sponsor: USMARI Research & Innovation Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Skin and Connective Tissue Diseases; Eczema
• Other Study ID Numbers: UMRAMREC005-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No