clinical Study of Pimecrolimus cream in Atopic dermatitis patients in India
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2024/03/063709
- Lead Sponsor
- Encube Ethicals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Non-immuno compromised male or non-pregnant, non-lactating female aged 12 years and older with a clinical diagnosis of mild to moderate atopic dermatitis.
2.Subject with clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable as per the Investigator.
3.Subject has confirmed diagnosis of atopic dermatitis for at least 3 months.
4.Subjects having an Investigator’s Global Assessment (IGA) of disease severity of mild or moderate at baseline. (a score of 2 (mild) or 3 (moderate)).
5.Subject having an affected area of atopic dermatitis involvement of at least 5 Percentage Body Surface Area (BSA) at baseline, as defined by the criteria of Hanifin and Rajka criteria.
6.Female subject must have a negative Urine Pregnancy Test at the time of screening or Female Subject of non-child bearing potential.
7.Female Subject of childbearing potential practicing an approved method of contraception that is stable at least 3 months prior to baseline and throughout the study. Acceptable forms of birth control include any of the following: (1) hormonal birth control, which must be stable for more than 3 months prior to baseline; (2) abstinence; subject must use condom plus spermicide if becomes sexually active; (3) double barrier method, such as condom plus spermicide.
8.Male Subject must use accepted methods of birth control or must agree to practice abstinence from study entry until the application of Investigational Product.
9.Willing to provide written informed consent or assent, as applicable. For Subjects who are considered minors (less than 18 completed years), the parent or legal guardian shall sign the consent form and the child shall be required to sign a Subject assent form, as appropriate.
1.Females who are pregnant, breastfeeding, or who wish to become pregnant during the study period.
2.Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
3.Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations.
4.History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
5.History or presence of Netherton’s Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
6.Concurrent disease or treatment likely to interfere with the study treatment or evaluations.
7.Use within one month prior to baseline of i) Oral or intravenous corticosteroids, ii) UVA/UVB therapy, iii) PUVA (psoralen plus ultraviolet A) therapy, iv) Tanning booths, v) Nonprescription UV light sources, vi) Immunomodulators or immunosuppressive therapies, vii) Interferon, viii) Cytotoxic drugs, ix) Tacrolimus and x) Pimecrolimus.
8.Use within 14 days of baseline of i) Systemic antibiotics, ii) Calcipotriene or other vitamin D preparations, iii) Retinoids.
9.Use within 7 days prior to baseline of i) Systemic antihistamines, ii) Topical antibiotics, iii) Topical corticosteroids, and iv) other topical drug products.
10.Use within 24 hours prior to baseline of any topical product (e.g., sunscreens, lotions, creams bland emollient/moisturizer) in the areas to be treated.
11.Known allergy or hypersensitivity to pimecrolimus or any other component of the test product or reference product
12.Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
13.Subject with clinically significant vital sign abnormality.
14.Subject with clinically significant unstable medical disorders, life-threatening disease.
15.Subject who has been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
16.Subject who are directly employed at the study site and are associated with conduct of this study.
17.Living in the same household of a subject who is currently participating in this study or living in the same household of a subject who has previously participated in this study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects in each treatment group with treatment success based on the Investigator’s Global Assessment of Disease Severity <br/ ><br>Clinical Success is defined as an IGA score of 0 or 1, within the treatment area. <br/ ><br>Clinical Failure is defined as an IGA score of more than 1. <br/ ><br>Timepoint: Baseline to Day 15
- Secondary Outcome Measures
Name Time Method Change in severity of four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification, and pruritus).Timepoint: Baseline to Day 15