Male and female patients aged 18 to 65 years with eczematous rash Madecassoside, Asiaticoside, eczema, nanogel cream, Centella asiatica containing product
Conditions
Interventions
The study product contains Centella asiatica extract standardized to ECa 233, concentration 0.20% w/w. in the topical cream form. ,Hydrocortisone is the topical medication primarily used to treat ecze
Study Product,1% Hydrocortisone
Sponsors
Kasikorn foundation
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male or female volunteers aged 18 to 65 years who have been clinically diagnosed by a dermatologist with eczema presenting as bilateral lesions of comparable size on both sides of the body. The difference in lesion area between the two sides must not exceed 10 percent of the total lesion surface area. Lesions may appear at any symmetrical body site such as left and right arms, left and right legs, or left and right sides of the waist. The duration of the lesions must be at least 1 week. 2.Volunteers who willingly consent to participate in the study and have signed the Informed Consent Form as written documentation of voluntary participation. 3.Volunteers who are able to comply with all study procedures and attend all scheduled follow-up visits throughout the 6-week study period.
Exclusion criteria
Exclusion criteria: 1.Volunteers with a history of taking oral or injectable medications that affect skin inflammation or allergic reactions, such as corticosteroids, antihistamines, anti-inflammatory drugs, or immunosuppressants, within 4 weeks prior to study enrollment. 2.Volunteers with a history of using topical medications that affect skin inflammation or allergic reactions, such as corticosteroids, calcineurin inhibitors, or moisturizing creams, within 2 weeks prior to study enrollment. 3.Volunteers with skin infections at the test area. 4.Volunteers with a history of allergic reactions to any components of the study products. 5.Female volunteers who are planning to become pregnant, are currently pregnant, or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema index at 0, 1, 2, 4, 6 weeks after treatment initiation Chromameter,Hydration at 0, 1, 2, 4, 6 weeks after treatment initiation Corneometer,Transepidernal water loss at 0, 1, 2, 4, 6 weeks after treatment initiation Tewameter,pH at 0, 1, 2, 4, 6 weeks after treatment initiation Skin-pH-Meter PH 905 | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythema at 1, 2, 4, 6 weeks after treatment initiation physician clinical improvement score ,Roughness at 1, 2, 4, 6 weeks after treatment initiation physician clinical improvement score ,Scaliness at 1, 2, 4, 6 weeks after treatment initiation physician clinical improvement score ,Itchyness at 0, 1, 2, 4, 6 weeks after treatment initiation Visual analog scale,satisfaction level at 6 weeks after treatment initiation Patient Global Assessment | — |
Countries
Thailand
Contacts
Public ContactPawinee Rerknimitr
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed