A prospective, open label,multicenter study on efficacy and safety of topical Dewderm AD cream in mild to moderate Atopic Dermatitis.

Sami Labs Limited0 个研究点目标入组 36 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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 ( < 6 months) active or presence of current superficial skin infections of viral etiology such as herpes simplex, or varicella.
•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.

发起方

Sami Labs Limited