Topical Roflumilast in Adults With Atopic Dermatitis

NCT01856764 | Completed Phase 2 Results

• 3 other identifiers: ROF-DERM_2032012-003000-12U1111-1133-6455
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)

  Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.

  Baseline and Day 15

Secondary Outcomes (2)

• Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values

  Baseline and Day 15

• Change From Baseline to Day 15 in Participants' Assessment of Pruritus

  Baseline and Day 15

Study Arms (2)

0.5% Roflumilast Cream

EXPERIMENTAL

Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.

Drug: 0.5% Roflumilast Cream

Vehicle Cream

PLACEBO COMPARATOR

Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.

Drug: Vehicle Cream

Interventions

0.5% Roflumilast Cream DRUG

Roflumilast 0.5% cream

0.5% Roflumilast Cream

Vehicle Cream DRUG

Roflumilast formulation vehicle

Vehicle Cream

Eligibility Criteria

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

You may qualify if:

• Is male or female between 18 to 65 years of age, inclusive, with atopic dermatitis (AD) meeting Hanifin and Rajka's criteria.
• Has lesional skin areas of moderate severity characterized by modified local SCORing Atopic Dermatitis (SCORAD) of at least 4, with an erythema score ≥2, and confirmed by a qualified investigator.
• Has an index/target lesion of moderate severity approximately 20 cm\^2, suitable for topical treatment.
• Is willing to wash out from AD current active therapy prior to entry in the study.
• Is willing and able to apply the study medication as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
• If a male who is nonsterilized and sexually active with a female partner of childbearing potential, agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
• If a female of childbearing potential who is sexually active with a nonsterilized male partner, agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
• Is capable of understanding and complying with protocol requirements in the opinion of the investigator.
• Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

You may not qualify if:

• Has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening visit.
• Has a history of AD unresponsive or poorly responsive to topical treatments.
• Has a history of hypersensitivity to phosphodiesterase (PDE)-4 inhibitors or to drugs of similar chemical classes or any inactive ingredients of the trial medication.
• Has clinically significant abnormal hematological parameters of hemoglobin, hematocrit or erythrocytes at Screening, in the judgment of the investigator.
• Has a history or current clinically relevant allergy or idiosyncrasy to drugs or food.
• Had extensive exposure to ultraviolet (UV) light in the 4 weeks prior to first application of study medication, including tanning and sun beds or is intending to have such exposure during the study treatment that may interfere with the study assessments as judged by the investigator.
• Has evidence of oozing of target lesion.
• Has a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated.
• Had systemic treatment with corticosteroids or retinoids for studied condition within 3 months prior to the first application of study medication.
• 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 4 weeks prior to first application of study medication.
• Had treatment with systemic/locally acting medications/procedures that might counter or influence the study aim within 4 weeks prior to first application of study medication and during the study (e.g., anti-histamines).
• Has used emollients/moisturizers on areas to be treated within 24 hours prior to the first application of study medication.
• Has used biologics at any time for treatment of AD.
• Is currently enrolled in an investigational drug or device study.
• Has any clinically significant illness that may influence the outcome of the trial from 4 weeks before Day 1 through trial completion.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Hamburg, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 14, 2013
• First Posted: May 17, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 1, 2017
• Results First Posted: July 7, 2015

Record last verified: 2016-09

Locations

DE (3)