Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03058744

Enrollment

Registered

2017-02-23

Start date

2015-04-30

Completion date

2017-01-31

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Detailed description

A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Interventions

DRUGTazorac Cream

Cream

DRUGUltravate Cream

Cream

DRUGIDP-118 Lotion

Lotion

DRUGHP Monad Lotion

Lotion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or Female of any race, at least 18 years old of age (inclusive) * Freely provides both written and oral informed consent. * Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation. * Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%. * The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. Key

Exclusion criteria

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator. * Presents with psoriasis that was treated with prescription medication and failed to respond to presents). * Has a history of adrenal disease. * Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator. * Is pregnant, nursing, or planning pregnancy during the study period.

Design outcomes

Primary

Measure	Time frame	Description
Local Skin Reactions (LSRs)	8 Weeks	Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026