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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058744
• Other study ID #: V01-118A-501
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2016
• Last updated: June 8, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IDP-118 Lotion
Lotion
• HP Monad Lotion
Lotion
• Ultravate Cream
Cream
• Tazorac Cream
Cream

Locations

Country	Name	City	State
United States	Valeant Site 12	Anaheim	California
United States	Valeant Site 08	Atlanta	Georgia
United States	Valeant Site 03	Austin	Texas
United States	Valeant Site 05	Encino	California
United States	Valeant Site 02	Katy	Texas
United States	Valeant Site 06	New York	New York
United States	Valeant Site 10	Orange Park	Florida
United States	Valeant Site 11	Philadelphia	Pennsylvania
United States	Valeant Site 04	Plainfield	Indiana
United States	Valeant Site 01	San Diego	California
United States	Valeant Site 09	Sanford	Florida
United States	Valeant Site 07	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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