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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: AN2728 Topical Ointment, 0.5% BID; Drug: AN2728 Topical Ointment, 2% QD; Drug: AN2728 Topical Ointment, 2% BID; Drug: AN2728 Topical Ointment, 0.5% QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT01602341

AN2728-AD-204

Details and patient eligibility

About

The 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)

Enrollment: 86 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

86 participants in 2 patient groups

AN2728 Topical Ointment, 2% QD vs 0.5% QD

Experimental group

Description:

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.

Treatment:

Drug: AN2728 Topical Ointment, 2% QD

Drug: AN2728 Topical Ointment, 0.5% QD

AN2728 Topical Ointment, 2% BID vs 0.5% BID

Experimental group

Description:

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.

Treatment:

Drug: AN2728 Topical Ointment, 0.5% BID

Drug: AN2728 Topical Ointment, 2% BID