Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque
Psoriasis

Key Inclusion Criteria:

- Male or female, of any race, at least 18 years of age (inclusive).

- Freely provides both verbal and written informed consent.

- Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA
(Body Surface Area) of at least 3%, but no more than 12%. The face, scalp, palms,
soles, axillae, and intertriginous areas are to be excluded in this calculation.

- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
radiation (natural and artificial) for the duration of the study.

- Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA (Investigators
Global Assessment) score of 3 or 4. (The face, scalp, palms, soles, axillae, and
intertriginous areas are to be excluded in this assessment, if psoriasis is present.)

- If female and of childbearing potential, must have a negative urine and serum
pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit
prior to randomization.

- Subject is willing to comply with study instructions and return to the clinic for
required visits.

Key Exclusion Criteria:

- Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
psoriasis, as determined by the investigator.

- Presents with psoriasis that was treated with prescription medication and failed to
respond to treatment, even partially or temporarily, as determined by the
investigator.

- Presents with any concurrent skin condition that could interfere with the evaluation
of the treatment areas, as determined by the investigator.

- Is pregnant, nursing an infant, or planning a pregnancy during the study period.

- Has received treatment with any investigational drug or device within 60 days or 5
drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently
participating in another clinical study with an investigational drug or device.