Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis

NCT03297502 | Completed Phase 3

• 1 other identifier: SYM 2016-01
• Study Type: interventional
• Target: 582
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus Cream, 1%). The study compares both active treatments to a placebo control in the treatment of mild to moderate atopic dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with treatment success in each treatment group

  Treatment success is defined as an Investigator's Global Assessment (IGA) Rating of "clear" or "almost clear" ( i.e., a score of 0 or 1 on a scale of 0 \[clear\] through 4. IGA Scale: 0 = Clear (minor discoloration, no erythema, induration, population, oozing/crusting. 1= Almost Clear (trace, faint erythema, almost no induration/population, no oozing/crusting. 2 = Mild (faint erythema, mild induration/population, no oozing/crusting. 3 = Moderate (Pink-red erythema, moderate induration/population, some oozing/crusting. 4 = Severe (Deep/bright erythema, severe induration/population, with oozing/crusting.

  Day 15

Secondary Outcomes (4)

• Change from baseline in severity (erythema)

  Baseline, Day 15

• Change from baseline in severity (induration/population)

  Baseline, Day 15

• Change from baseline in severity (lichenification)

  Baseline, Day 15

• Change from baseline in severity (pruritis)

  Baseline, Day 15

Study Arms (3)

Pimecrolimus cream, 1%

EXPERIMENTAL

Drug: pimecrolimus cream 1%

Elidel (pimecrolimus) cream 1%

ACTIVE COMPARATOR

Drug: Elidel (pimecrolimus) cream 1%

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

pimecrolimus cream 1% DRUG

Pimecrolimus cream, 1%

Elidel (pimecrolimus) cream 1% DRUG

Elidel (pimecrolimus) cream 1%

placebo DRUG

placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent/assent for the study.
• Non-immunocompromised male or female aged 12 years or older.
• A clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or subjects for whom the use of those other treatments is deemed inadvisable.
• A diagnosis of atopic dermatitis for at least 3 months.
• A baseline Investigator's Global Assessment (IGA) of disease severity of mild or moderate (score of 2 or 3). (See Section 9.6.10 for the scale.)
• An affected area of atopic dermatitis involvement of at least 5% of the body surface area (BSA) at Visit 2/Day 1 (Baseline), as defined by the criteria of Hanifin and Rajka (1980).
• Treatment with a bland emollient for at least 7 days prior to Visit 2/Day 1 (Baseline).
• Agree to adhere to protocol-specified requirements and concomitant therapy restrictions.
• Willing to avoid constant sun exposure and the use of tanning booths or other UV light sources during participation in the study.
• In general good health, non-immunocompromised, and free from any clinically significant disease, other than atopic dermatitis, that might interfere with the study evaluations.
• Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required study visits, comply with therapy prohibitions, and complete the study.
• Female subjects of childbearing potential (excluding women who are surgically sterilized \[hysterectomy, bilateral tubal ligation, or bilateral ovariectomy\] or have been postmenopausal for at least 1 year) must have a negative urine pregnancy test and must be willing to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), Essure® permanent birth control, and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active.

You may not qualify if:

• Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
• Active cutaneous bacterial or viral infection in any proposed treatment area at Visit 2/Baseline (e.g., clinically infected atopic dermatitis).
• Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Visit 2/Baseline that would interfere with the study evaluations.
• History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
• 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.
• Use of any treatment listed in Table 9.1 more recently than the indicated washout period prior to Visit 2/Baseline.
• Need or intent to continue to use any treatment listed in Table 9.1 during the current study.
• Table 9.1 Medications, Supplements, and Other Substances Prohibited for Study Entry Prohibited Medications, Supplements, and Other Substances Washout Period Prior to Randomization Visit 2/Baseline
• Systemic corticosteroids (oral and injectable \[intravenous and intramuscular\]) (Intranasal and Inhalational steroids are allowed if use is kept constant during the study)
• UVA/UVB therapy
• PUVA (psoralen plus ultraviolet A) therapy
• Tanning booths
• Nonprescription UV light sources
• Immunomodulators or immunosuppressive therapies
• Interferon

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew Davis, MD, RPh

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 29, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 29, 2017

Record last verified: 2017-09