Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

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NCT01301508

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Study Location
Anacor Investigational Site
Kogarah, New South Wales, 2217, Australia
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Contact
1-800-718-1021
ClinicalTrials.gov_Inquir[email protected]
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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

By email

Contact

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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
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month

- Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin

- Presence of two (2) comparable target lesions

- Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits

- Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Concurrent or recent use of certain topical or systemic medications or phototherapy
without a sufficient washout period


- Active or potentially recurrent dermatologic condition other than atopic dermatitis in
the target lesion area that may confound evaluation


- Significant confounding conditions as assessed by study doctor


- History or evidence of allergies requiring acute or chronic treatment (except seasonal
allergic rhinitis)


- Participated in any other trial of an investigational drug or device within 30 days or
participation in a research study concurrent with this study


- Pregnancy or lactation

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
Official Title  ICMJE A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis
Brief Summary The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
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 Dermatitis, Atopic
Intervention  ICMJE
  • Drug: AN2728 ointment, 2%
    AN2728 ointment, 2%, applied twice daily for 6 weeks
  • Drug: AN2898 ointment, 1%
    AN2898 ointment, 1%, applied twice daily for 6 weeks
  • Drug: AN2898 ointment vehicle
    AN2898 ointment vehicle applied twice daily for 6 weeks
  • Drug: AN2728 ointment vehicle
    AN2728 ointment vehicle applied twice daily for 6 weeks
Study Arms  ICMJE
  • Experimental: AN2898 ointment, 1%, vs. ointment vehicle

    AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

    Treatments will be randomly assigned to target lesions A and B.

    Interventions:
    • Drug: AN2898 ointment, 1%
    • Drug: AN2898 ointment vehicle
  • Experimental: AN2728 ointment, 2%, vs. ointment vehicle

    AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

    Treatments will be randomly assigned to target lesions A and B.

    Interventions:
    • Drug: AN2728 ointment, 2%
    • Drug: AN2728 ointment vehicle
Publications * Murrell DF, Gebauer K, Spelman L, Zane LT. Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study. J Drugs Dermatol. 2015 Oct;14(10):1108-12.

*   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
 (submitted: December 13, 2011)		46
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2011)		120
Actual Study Completion Date  ICMJE November 11, 2011
Actual Primary Completion Date November 11, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of atopic dermatitis that has been clinically stable for ?1 month
  • Total body surface area (BSA) of atopic dermatitis involvement ?35%, excluding involvement of the face, scalp, and groin
  • Presence of two (2) comparable target lesions
  • Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
  • Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria:

  • Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
  • Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
  • Significant confounding conditions as assessed by study doctor
  • History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • Pregnancy or lactation
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01301508
Other Study ID Numbers  ICMJE AN2898-AD-202
C3471001 ( Other Identifier: Pfizer )
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP