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Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

Last updated on May 10, 2018

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Study Location
Anacor Investigational Site
Fremont, California, 94538 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)

- AD in treatable areas (excludes the scalp and venous access areas) involving

≥10% and ≤35% of the total body surface area(BSA)

- Investigator's Static Global Assessment (ISGA) score of 2 or 3

- Normal or not clinically significant screening laboratory results

- Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through
uninfected skin that has not been treated with study drug; each untreated venous
access area should provide a margin of at least 5 cm radius around the venipuncture
site

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

- Females must use a highly effective method of birth control.

- 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
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

NCT01652885
Pfizer
Completed
Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

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Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis
An Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN2728 Ointment in Adolescents With Atopic Dermatitis
The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dermatitis, Atopic
Drug: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%
Experimental: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
Intervention: Drug: AN2728 Topical Ointment, 2%
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
November 2012
October 2012   (Final data collection date for primary outcome measure)

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)
  • AD in treatable areas (excludes the scalp and venous access areas) involving

    ?10% and ?35% of the total body surface area(BSA)

  • Investigator's Static Global Assessment (ISGA) score of 2 or 3
  • Normal or not clinically significant screening laboratory results
  • Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site
  • Willing and able to comply with study instructions and commit to attending all visits
  • Females must use a highly effective method of birth control.
  • 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 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
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01652885
AN2728-AD-203
A3191007 ( Other Identifier: Pfizer )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

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

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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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