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

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NCT01301508

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Anacor Investigational Site
Kogarah, New South Wales, 2217 Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01301508
Pfizer
Completed
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

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Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
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
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dermatitis, Atopic
  • 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
  • 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
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.
 
Completed
46
Not Provided
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01301508
AN2898-AD-202
C3471001 ( Other Identifier: Pfizer )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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