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

NCT07463079 | Recruiting

• 1 other identifier: UMRAMREC005-25
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 1.To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia.
2. 2.To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia.
3. 3.To assess the participants' satisfaction after using the moisturizing lotion.

Conditions

Eczema

Outcome Measures

Primary Outcomes (3)

• 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 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

  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 Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  4 weeks

• Participant satisfaction

  week 4

Study Arms (1)

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

Other: Moisturizing lotion

Interventions

Moisturizing lotion OTHER

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

Moisturizing lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• USMARI Research & Innovation Centre: lead

Study Sites (1)

USMARI Research & Innovation Centre

Petaling Jaya, Selangor, 47810, Malaysia

RECRUITING

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: February 1, 2026
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)