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Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

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Bausch Health

Status and phase

Completed
Phase 2

Conditions

Psoriasis

Treatments

Drug: IDP-122 Vehicle Lotion
Drug: Ultravate Cream
Drug: IDP-122 Vehicle Cream
Drug: IDP-122 Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT02785185
V01-122A-203

Details and patient eligibility

About

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Full description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Male or female, of any race, at least 18 years of age (inclusive).
  • Freely provides both verbal and written informed consent.
  • Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 4 patient groups

IDP-122 Lotion
Experimental group
Description:
Lotion
Treatment:
Drug: IDP-122 Lotion
Ultravate Cream
Active Comparator group
Description:
Cream
Treatment:
Drug: Ultravate Cream
IDP-122 Vehicle Lotion
Active Comparator group
Description:
Lotion
Treatment:
Drug: IDP-122 Vehicle Lotion
IDP-122 Vehicle Cream
Active Comparator group
Description:
Cream
Treatment:
Drug: IDP-122 Vehicle Cream

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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