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NCT Number: NCT07463079

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USMARI Research & Innovation Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location status: Recruiting

Location contact

Siti Nur Hanis Mamood, PhD

CONTACT

[email protected]

+60167572670

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moisturizing lotion

Other

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

Primary outcomes

  1. 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).

  2. 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

    • = 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

  3. 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.

Secondary outcomes

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

    Time frame: 4 weeks

    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

  2. Participant satisfaction

    Time frame: week 4

    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).

Sponsors and collaborators

Lead sponsor

USMARI Research & Innovation Centre

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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