Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Dewderm AD cream: Twice daily topical application on the areas affected with atopic dermatitis for 60 days.
Control Intervention1: NIL: NIL
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female subjects between 5 to 55 years of age, both exclusive(at least 10 children to be enrolled) and with a diagnosis of atopic dermatitis who are otherwise healthy. 2 Diagnosis of mild to moderate Atopic Dermatitis a Atopic Dermatitis as defined by Hannifin and Rajka diagnostic criteria. b Mild to moderate Atopic Dermatitis as defined by a SCORAD score of up to 50. 3 Healthy as determined through physical examination. 4 Subjects willing to give a written informed consent and come for a regular follow up. 5 Subject willing to abide by and comply with the study protocol. 6 Subject has not participated in a similar investigation in the past four weeks. 7 Subject willing to refrain from current active therapy for at least 10 days prior to the application of the study cream.
Exclusion criteria
Exclusion criteria: 1 Subject presented with any systemic disorder or active skin disease (other than atopic dermatitis) (e.g. Psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessments of lesions at Screening. 2 Subject had a current complication of Atopic Dermatitis such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated. 3 History of recent ( 4 Subject had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. 5 Subject had systemic treatment for atopic dermatitis (including corticosteroids, cyclosporine, tacrolimus, methotrexate, PUVA, or UVB) within 28 days of the first application of the study medication. 6 History of skin allergy to any of the ingredients used in the formulation. 7 Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Skin surface Hydration. 2 Scoring Atopic Dermatitis. 3 Investigatorâ??s Global Assessment. 4 Clinical Photographs. 5 Dermatology Life Quality Index.Timepoint: 1 Skin surface Hydration(Baseline and Visit 5). 2 Scoring Atopic Dermatitis(Screening, Visit 3, Visit 4 and visit 5). 3 Investigatorâ??s Global Assessment(Baseline and Visit 5). 4 Clinical Photographs(Baseline, Visit 3, Visit 4 and Visit 5). 5 Dermatology Life Quality Index(Baseline, Visit 3, Visit 4 and Visit 5). | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment Adverse Events.Timepoint: Assessment Adverse Events(Visit 3, Visit 4 and Visit 5). | — |
Countries
India
Contacts
Public ContactMr Sanjib Panda
ClinWorld Private Limited
Outcome results
None listed