Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 19, 2015
End Date:November 14, 2016

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A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess
the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

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.
We found this trial at
15
sites
Fremont, California 94536
1319
mi
from
Fremont, CA
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Albuquerque, New Mexico 87103
524
mi
from
Albuquerque, NM
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Boynton Beach, Florida 33424
1291
mi
from
Boynton Beach, FL
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College Station, Texas 77845
499
mi
from
College Station, TX
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Detroit, Michigan 48201
841
mi
from
Detroit, MI
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East Windsor, New Jersey
1258
mi
from
East Windsor, NJ
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Fridley, Minnesota 55432
559
mi
from
Fridley, MN
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High Point, North Carolina 27262
989
mi
from
High Point, NC
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Houston, Texas 77065
569
mi
from
Houston, TX
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Knoxville, Tennessee 37909
771
mi
from
Knoxville, TN
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New York, New York 10075
1289
mi
from
New York, NY
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North Miami Beach, Florida 33162
1315
mi
from
North Miami Beach, FL
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Pflugerville, Texas 78660
505
mi
from
Pflugerville, TX
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Portland, Oregon 97201
1384
mi
from
Portland, OR
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Warren, Michigan 48088
848
mi
from
Warren, MI
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