- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118766
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
January 12, 2017 updated by: Pfizer
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
763
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Stockbridge, Georgia, United States
- Anacor Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females 2 years and older
- Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka
- Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
- Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
- All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug
Exclusion Criteria:
- As determined by the study doctor, a medical history that may interfere with study objectives
- Unstable AD or any consistent requirement for high potency topical corticosteroids
- History of use of biologic therapy (including intravenous immunoglobulin)
- Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
- Recent or current participation in another research study
- Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
- Participation in a previous AN2728 clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
|
|
PLACEBO_COMPARATOR: Matching vehicle control
Matching vehicle control, applied twice daily for up to 28 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29
Time Frame: Day 29
|
ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD.
Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, 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 an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.
|
Day 29
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Time Frame: AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36
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An AE was any untoward medical occurrence attributed to 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 end of study that were absent before treatment or that worsened relative to pre-treatment state.
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AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29
Time Frame: Baseline, Day 29
|
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature.
Vital sign measurements were performed with the participant in the seated or supine position.
Clinical significance of change from baseline value was determined by investigator.
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Baseline, Day 29
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29
Time Frame: Baseline, Day 29
|
Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium.
Clinical significance of change from baseline value was determined by investigator.
|
Baseline, Day 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29
Time Frame: Day 29
|
ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD.
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).
Percentage of participants with an ISGA score of 0 or 1 were reported.
|
Day 29
|
Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)
Time Frame: Baseline (Day 1) up to Day 29
|
Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA.
Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline.
It was analyzed using Kaplan-Meier method.
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Baseline (Day 1) up to Day 29
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Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29
Time Frame: Baseline, Day 29
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Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification.
Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe.
Higher score indicates severe signs and symptoms of AD.
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Baseline, Day 29
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Improvement in Pruritus
Time Frame: Baseline up to Day 29
|
Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus.
Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline.
Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep).
Higher scores indicated more severe condition.
It was analyzed using Kaplan-Meier method.
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Baseline up to Day 29
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Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29
Time Frame: Baseline, Day 29
|
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life.
Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life.
The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life.
Higher scores indicate more impact on quality of life of participants.
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Baseline, Day 29
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Luger TA, Hebert AA, Zaenglein AL, Silverberg JI, Tan H, Ports WC, Zielinski MA. Subgroup Analysis of Crisaborole for Mild-to-Moderate Atopic Dermatitis in Children Aged 2 to < 18 Years. Paediatr Drugs. 2022 Mar;24(2):175-183. doi: 10.1007/s40272-021-00490-y. Epub 2022 Mar 16.
- Geng B, Hebert AA, Takiya L, Miller L, Werth JL, Zang C, Sanders P, Lebwohl MG. Efficacy and Safety Trends with Continuous, Long-Term Crisaborole Use in Patients Aged >/= 2 Years with Mild-to-Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Oct;11(5):1667-1678. doi: 10.1007/s13555-021-00584-y. Epub 2021 Aug 11. Erratum In: Dermatol Ther (Heidelb). 2021 Sep 22;:
- Thyssen JP, Zang C, Neary MP, Bushmakin AG, Cappelleri JC, Cha A, Russo C, Luger TA. Translating the Investigator's Static Global Assessment to the Eczema Area and Severity Index in Studies of Crisaborole for Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Jun;11(3):845-853. doi: 10.1007/s13555-021-00509-9. Epub 2021 Mar 13.
- Stein Gold LF, Takiya L, Zang C, Sanders P, Feldman SR. Demographics and Baseline Disease Characteristics of Early Responders to Crisaborole for Atopic Dermatitis. J Drugs Dermatol. 2020 Jun 1;19(6):619-624.
- Silverberg JI, Tallman AM, Ports WC, Gerber RA, Tan H, Zielinski MA. Evaluating the Efficacy of Crisaborole Using the Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area. Acta Derm Venereol. 2020 Jun 11;100(13):adv00170. doi: 10.2340/00015555-3489.
- Simpson EL, Paller AS, Boguniewicz M, Eichenfield LF, Feldman SR, Silverberg JI, Chamlin SL, Zane LT. Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families. Dermatol Ther (Heidelb). 2018 Dec;8(4):605-619. doi: 10.1007/s13555-018-0263-0. Epub 2018 Oct 22.
- Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11. Erratum In: J Am Acad Dermatol. 2017 Apr;76(4):777.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ACTUAL)
April 1, 2015
Study Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
April 15, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (ESTIMATE)
April 21, 2014
Study Record Updates
Last Update Posted (ACTUAL)
March 6, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN2728-AD-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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