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Completed

NCT Number: NCT03107611

Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.

To establish superiority of each active treatment over the placebo.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Facility 11, Santo Domingo, Dominican Republic

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-immuno compromised male or female aged 8 years and older
  • Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
  • Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
  • A diagnosis of AD for at least 3 months
  • An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
  • Affected area of AD involvement at least 5% body surface area (BSA)
  • Treated with a bland emollient for at least 7 days

Exclusion criteria

  • Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
  • Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
  • Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
  • History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
  • 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
  • Concurrent disease or treatment likely to interfere with the study treatment or evaluations
  • Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
  • Not willing to minimize or avoid natural and artificial sunlight exposure during treatment

Treatment and study plan

Pimecrolimus Cream, 1%

Drug

placebo cream

Drug

Primary outcomes

  1. Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])

    Time frame: Day 15

    Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting

  2. Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])

    Time frame: Day 15

    Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting

Secondary outcomes

  1. Change in Severity of Four Individual Signs and Symptoms

    Time frame: Day 15

    Erythema, induration/papulation, lichenification and pruritus

  2. Evaluation of Application Site Reactions

    Time frame: Day 15

    Dryness, burning/stinging, erosion, edema, and pain

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • DPT Laboratories, Ltd.

Registry information

Official study title

A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2017
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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