Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
NCT03903822
Last updated date
ABOUT THIS STUDY
This study is being conducted to provide data on efficacy, safety, tolerability and PK of
multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of
mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the
dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future
clinical development of topical PF-06700841.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
12-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Clinical diagnosis of Atopic Dermatitis for at least 3 months
- Investigator's Global Assessment (IGA) Score of 2 or 3
- Eczema Area Severity Index (EASI) score of 3-21
- Body Surface Area (BSA) of 2-20%
- Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Other forms of dermatological diseases (other than atopic dermatitis)
- Fitzpatrick skin type score greater than 5
- Clinically significant abnormal ECG, vital signs, and laboratory values
- Infection with HBV, HCV, herpes zoster or tuberculosis
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis | ||||
| Official Title ICMJE | A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS | ||||
| Brief Summary | This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
| Condition ICMJE | Atopic Dermatitis | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
* 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 | 293 | ||||
| Original Estimated Enrollment ICMJE | 280 | ||||
| Actual Study Completion Date ICMJE | May 7, 2020 | ||||
| Actual Primary Completion Date | May 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 12 Years to 75 Years (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 | Australia, Bulgaria, Canada, Denmark, Germany, Hungary, Japan, Latvia, Poland, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03903822 | ||||
| Other Study ID Numbers ICMJE | B7931022 2018-003050-24 ( EudraCT Number ) | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||
| Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||