A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118

Dova Pharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Plaque Psoriasis

Treatments

Drug: IDP-118 High Strength

Drug: IDP-118 Low Strength

Study type

Interventional

Funder types

Industry

Identifiers

NCT01670513

DPSI-IDP-118-P2-01

Details and patient eligibility

About

Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.

Full description

Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female of any race, 18 to 65 (inclusive) years of age.
Freely given verbal and written informed consent obtained from the subject.
Clinical diagnosis of psoriasis at the Screening and Baseline visits with
At least 10% - 20% of total treatable BSA involvement, and
an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5
Good general health as determined by the Investigator based on the subject's medical history and physical examination, with Screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits.

Exclusion criteria

Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator.
Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator.
History of adrenal disease
Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.