Health TrialsbyHealthPanel

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

ConditionEczema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUSMARI Research & Innovation Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Moisturizing lotion

    Other intervention

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Moisturizing lotionOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

USMARI Research & Innovation Centre

Lead sponsor

Source ClinicalTrials.gov
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