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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01652885
First received: July 20, 2012
Last updated: March 12, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.

Condition Intervention Phase
Dermatitis, Atopic Drug: AN2728 Topical Ointment, 2% Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN2728 Ointment in Adolescents With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Local Tolerability Symptoms According to Severity on Baseline [ Time Frame: Baseline ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 2 [ Time Frame: Day 2 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 4 [ Time Frame: Day 4 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 6 [ Time Frame: Day 6 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 8 [ Time Frame: Day 8 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 9 [ Time Frame: Day 9 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 15 [ Time Frame: Day 15 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 22 [ Time Frame: Day 22 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure.

  • Number of Participants With Local Tolerability Symptoms According to Severity on Day 29 [ Time Frame: Day 29 ]
    Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure.

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Day 1) up to Day 29 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state.

  • Number of Participants With Clinically Significant Vital Signs Abnormalities [ Time Frame: Baseline (Day 1) up to Day 29 ]
    Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.

  • Number of Participants With Clinically Significant Laboratory Test Abnormalities [ Time Frame: Baseline (Day 1) up to Day 29 ]
    Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.

  • Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 ]
    Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 ]
    Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.

  • Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1 ]
    Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.

  • Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 ]
    Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.

  • Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 ]
    Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 ]
    Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.

  • Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8 ]
    Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.

  • Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 [ Time Frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8 ]
    Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.


Secondary Outcome Measures:
  • Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) [ Time Frame: Baseline up to Day 29 ]
    ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29.

  • Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22, 29 ]
    5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis.


Enrollment: 23
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
Drug: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652885

Locations
United States, California
Anacor Investigational Site
Fremont, California, United States, 94538
Anacor Investigational Site
San Diego, California, United States, 92123
United States, Indiana
Anacor Investigational Site
Indianapolis, Indiana, United States, 46256
United States, North Carolina
Anacor Investigational Site
High Point, North Carolina, United States, 27262
Anacor Investigational Site
Winston-Salem, North Carolina, United States, 27104
United States, Texas
Anacor Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01652885     History of Changes
Other Study ID Numbers: AN2728-AD-203
A3191007 ( Other Identifier: Pfizer )
Study First Received: July 20, 2012
Results First Received: January 11, 2017
Last Updated: March 12, 2017

Keywords provided by Pfizer:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 22, 2017