None listed
Conditions
Interventions
Intervention1: ELOVERA AD
LOTION (7B250222): The product is applied on the Atopic dermatitis affected area twice in a day for the period of 7 days.
Control Intervention1: Nil: NA
Sponsors
Glenmark Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Indian boy and girl subjects, with no history or current signs of infectious or progressive disease that could render the subject vulnerable or lead to discontinuation of the study, and no medical conditions or symptoms that could interfere with the study outcomes or that are under investigation in an exploratory diagnosis. 2)Diagnosed with atopic dermatitis 3)Itching must be present but limited in area not extensive, not too intense, and without excessive scaling or marked redness. 4)Site of atopic dermatitis: Flexural areas:Inside the elbows and behind the knees (classic sites), Neck: Predominantly on the anterior (front) aspect, Wrists and ankles: Involvement of the flexural (inner) surfaces,Hands and feet: Commonly affects the dorsal (back) surfaces 5)Skin characteristics: Skin may appear dry, scaly, or thickened due to chronic scratching 6)Informed consent form and assent form will be mandatory for all volunteers. In case a volunteer is unable to provide consent, parental or guardian consent will be obtained. 7)Specific criteria:Subjects with Atopic Dermatitis/Eczema (mild to moderate).
Exclusion criteria
Exclusion criteria: 1)Having refused to give his/her assent by not signing the consent form. 2)Taking part in another study liable to interfere with this study. 3)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 4)Having progressive asthma. 5)Being epileptic. 6)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 7)Having cutaneous hypersensitivity 8)Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products. 9)Following a chronic medicinal treatment comprising any of the following products: antiinflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10)Having any active bacterial, viral, or fungal infection on the study site. 11)Having severe or uncontrolled Atopic Dermatitis requiring systemic therapy. 12)Having any other dermatological or systemic condition that, in the investigator s opinion, could interfere with safety evaluation. 13)Subjects with infected, oozing, or severely excoriated or extreme redness lesions on the intended test area. 14)Subjects having received systemic immunosuppressive or biologic therapy (e.g. cyclosporine, methotrexate, dupilumab) within the previous 3 months. 15)Subjects having received topical calcineurin inhibitors (e.g. tacrolimus, pimecrolimus) or corticosteroids on the test site within 14 days prior to study start. 16) Subjects having received phototherapy (UVB or PUVA) within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product Safety on skin, Reduction in symptoms of Atopic Dermatitis or Eczema & improvement in skin hydrationTimepoint: Baseline and day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed