Bioequivalence Study of Pimecrolimus cream in Atopic dermatitis patients

Phase 1

Completed

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2018/11/016271
• Lead Sponsor: Encube Ethicals Private Ltd

Brief Summary

Its a Randomized, Double-Blind, Placebo-Controlled, three arms Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence and Safety of Pimecrolimus Cream, 1% (Encube Ethicals Private Limited)with Elidel® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis.



Approximately 588 males and non-pregnant females, 12 years of age and older, with mild to moderate Atopic Dermatitis.



Subject will have to do four clinic visit during the total duration of the study. The visit will include Visit 1 Screening visit, Visit 2 Randomization visit, Visit 3 Interim Visit and Visit 4 End of study/Early Termination visit.



Safety Evaluations will be performed in accordance with the study schematic. Safety assessments will include monitoring of adverse events (AEs) and application site reactions, vital sign measurements, urine pregnancy tests (for all women of childbearing potential).



The total duration of the study is 6 Months.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-11
• Study Completion: 2019-02-21
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 588

Inclusion Criteria

• 1.Non-immunocompromised male or non-pregnant, non-lactating female aged 12 years and older with a clinical diagnosis of mild to moderate atopic at the time of signing the informed consent.
• 2.Subjects have confirmed diagnosis of atopic dermatitis for at least 3 months.
• 3.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 per Investigator.
• 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)]and SCORAD score of disease severity should be in > 15 and <50.
• 5.Subjects having an affected area of AD involvement of at least 5% Body Surface Area (BSA) at baseline, as defined by the Hanifin and Rajkacriteria.
• 6.Subject is capable of understanding the purposes and risks of the trial and has given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• 8.Both male and female subjects of child bearing potential must be practicing adequate contraception (for example total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study and female subjects of childbearing potential must not be/likely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
• 9.Subject agrees to compliance with the protocol and adheres to the protocol requirements for the entire study period.

Exclusion Criteria

• 1.Subjects with diagnosis of atopic dermatitis for less than 3 months.
• 2.Reports active cutaneous bacterial or viral infection in any treatment area at baseline (e.g. Clinically infected atopic dermatitis).
• 3.Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations.
• 4.History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, orichthyosis.
• 5.Females who are pregnant, lactating or likely to become pregnant during the study.
• 6.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.
• 7.Use within one month prior to baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) PUVA (psoralen plus ultraviolet A) therapy, 4) tanning booths, 5) nonprescription UV light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) Tacrolimus, or 10) Pimecrolimus.
• 8.Use within 14 days of baseline of: 1) systemic antibiotics, 2) calcipotriene or other Vitamin D preparations, or 3) retinoids.
• 9.Use within 7 days prior to baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
• 10.Use within 24 hours prior to baseline of any topical product (e.g., sunscreens, lotions, creams) in the areas to be treated, except for bland emollient (moisturizer).
• Known allergy or hypersensitivity to Pimecrolimusor any other component of the test product or RLD.
• 12.Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.
• 13.Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
• 14.Demonstrates a positive test result for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody.
• 15.Reports simultaneous participation in any other drug trial or participation in any other trial involving investigational medicinal product within 30 days of randomization.
• However, subjects can be enrolled considering elimination half-life of study drug of last participation and/or pharmacokinetic profile of such drug molecule of last participation and/or other medical judgment (if any) to justify the subject’s participation based on investigator opinion and/or sponsor medical monitor.
• 16.Any other conditions that in the investigator’s judgment, might compromise subject safety or affect study results.
• 17.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints and/or might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
• 18.Employees of the Investigator or research centre or their immediate family members.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the proportion of subjects in the per protocol population in each treatment group with treatment Success at Day 15 ± 2. Treatment Success is defined as an IGA score of 0 (clear) or 1 (almost clear) within all treatment areas based on the investigator global assessment of disease at the end of treatment (week 4, study day 15)	Visit 1: Screening(Including 7 days run in period, subjects will | start the bland emollient immediately from the screening day | itself) |  Visit 2 Baseline (Day 0) |  Visit 3: Interim Visit (Day 8 ± 2) |  Visit 4: End of Study/Early Termination (Day15 ± 2) |  Safety Follow up Visit: 7 days after the last application of study | treatment. It can be performed telephonically.

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy endpoints are:	1.The proportion of subjects with Treatment Success at Day 15 ± 2.

Trial Locations

Locations (21)

Bodyline Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Ajanta Research Center, Ajanata Hospital and IVF Center,; 🇮🇳 Lucknow, UTTAR PRADESH, India

Apple Saraswati Multispeciality Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Dr. D Y Patil Medical College & Research Centre; 🇮🇳 (Suburban), MAHARASHTRA, India

G. T. Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

GMERS Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Hi Tech Multispeciality Hospital; 🇮🇳 Gandhinagar, GUJARAT, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

Joshi Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

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Bodyline Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Madhu Shah

Principal investigator

9824076703

drmshah61@gmail.com