Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

Taisho Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle; Drug: TS022

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914186

TS022-US201

Details and patient eligibility

About

The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.

Full description

(none provided)

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent
2. Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
3. A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
4. A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
5. Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
6. Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
7. Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure

Exclusion criteria

1. Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
2. Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
3. Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
4. Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
5. Inability or unwillingness to discontinue current AD treatment(s)
6. Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 4 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle

TS-022 0.005% lotion

Experimental group

Treatment:

Drug: TS022

TS-022 0.010% lotion

Experimental group

Treatment:

Drug: TS022

TS-022 0.020% lotion

Experimental group

Treatment:

Drug: TS022