Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
NCT02118792
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Males or females 2 years and older
- Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
- Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
- Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
- All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug
- As determined by the study doctor, a medical history that may interfere with study
objectives
- Unstable AD or any consistent requirement for high potency topical corticosteroids
- History of use of biologic therapy (including intravenous immunoglobulin)
- Recent or anticipated concomitant use of systemic or topical therapies that might
alter the course of AD
- Recent or current participation in another research study
- Females who are breastfeeding, pregnant, or with plans to get pregnant during the
participation in the study
- Participation in a previous AN2728 clinical trial
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Descriptive Information | ||||
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Brief Title ICMJE | Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis | |||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis | |||
Brief Summary | The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Dermatitis, Atopic | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 764 | |||
Original Estimated Enrollment ICMJE | 750 | |||
Actual Study Completion Date ICMJE | April 2015 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02118792 | |||
Other Study ID Numbers ICMJE | AN2728-AD-302 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |