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Completed

NCT Number: NCT03058744

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Valeant Site 12, Anaheim, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IDP-118 Lotion

Drug

Lotion

Other names: Lotion

HP Monad Lotion

Drug

Lotion

Other names: Lotion

Ultravate Cream

Drug

Cream

Other names: Ultravate

Tazorac Cream

Drug

Cream

Other names: Taz

Primary outcomes

  1. Local Skin Reactions (LSRs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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