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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02462070
Other study ID # V01-118A-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 11, 2015
Est. completion date December 1, 2016

Study information

Verified date August 2020
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of a topical lotion.


Description:

The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date December 1, 2016
Est. primary completion date November 8, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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 score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IDP-118 Lotion
Lotion
IDP-118 Vehicle Lotion
Lotion

Locations

Country Name City State
United States Valeant Site 5 Austin Texas
United States Valeant Site 9 Beverly Hills California
United States Valeant Site 13 Clinton Township Michigan
United States Valeant Site 16 Denver Colorado
United States Valeant Site 12 Encino California
United States Valeant Site 4 Houston Texas
United States Valeant Site 8 Louisville Kentucky
United States Valeant Site 3 Mobile Alabama
United States Valeant Site 6 Nashville Tennessee
United States Valeant Site 11 Norfolk Virginia
United States Valeant Site 14 Rochester New York
United States Valeant Site 10 San Diego California
United States Valeant Site 1 Santa Rosa California
United States Valeant Site 7 South Bend Indiana
United States Valeant Site 15 Spokane Washington
United States Valeant Site 2 Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Bausch Health Americas, Inc. Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Participants With Treatment Success at Week 8 Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. 8 weeks
Secondary Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. 12 weeks
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