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Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Anacor Investigational Site
Fremont, California, United States
Contact
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
12-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female 12 to 17 years of age, inclusive

- Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and
Rajka)

- Total body surface area (BSA) of atopic dermatitis involvement ≤35%

- Presence of two comparable target lesions

- Willing and able to comply with study instructions and commit to attending all visits

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

- Parent/guardian has the ability to understand, agree to and sign the study Informed
Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has
the ability to give assent

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

- Significant confounding conditions as assessed by study doctor

- Unstable or actively infected AD

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

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

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

- Treatment for any type of cancer (except squamous cell carcinoma, basal cell
carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or
surgical excision only) within the last 5 years

- Current pregnancy or lactation, or intent to become pregnant during the study

- Known sensitivity to any of the components of the study drug

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

- Participated in a previous AN2728 clinical study

NCT01602341
Pfizer
Completed
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

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Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis
Brief SummaryThe purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)
Detailed DescriptionNot 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 Topical Ointment, 2% QD
    AN2728 Topical Ointment, 2% QD
  • Drug: AN2728 Topical Ointment, 0.5% QD
    AN2728 Topical Ointment, 0.5% QD
  • Drug: AN2728 Topical Ointment, 2% BID
    AN2728 Topical Ointment, 2% BID
  • Drug: AN2728 Topical Ointment, 0.5% BID
    AN2728 Topical Ointment, 0.5% BID
Study Arms  ICMJE
  • Experimental: AN2728 Topical Ointment, 2% QD vs 0.5% QD

    AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion

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

    Interventions:
    • Drug: AN2728 Topical Ointment, 2% QD
    • Drug: AN2728 Topical Ointment, 0.5% QD
  • Experimental: AN2728 Topical Ointment, 2% BID vs 0.5% BID

    AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion.

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

    Interventions:
    • Drug: AN2728 Topical Ointment, 2% BID
    • Drug: AN2728 Topical Ointment, 0.5% BID
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
 (submitted: January 8, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2012)
80
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion DateJanuary 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female 12 to 17 years of age, inclusive
  • Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
  • Total body surface area (BSA) of atopic dermatitis involvement ?35%
  • Presence of two comparable target lesions
  • Willing and able to comply with study instructions and commit to attending all visits
  • Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
  • Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion Criteria:

  • Significant confounding conditions as assessed by study doctor
  • Unstable or actively infected AD
  • Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
  • History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
  • Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
  • Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
  • Current pregnancy or lactation, or intent to become pregnant during the study
  • Known sensitivity to any of the components of the study drug
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • Participated in a previous AN2728 clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602341
Other Study ID Numbers  ICMJE AN2728-AD-204
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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