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A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

Taro Pharmaceuticals logo

Taro Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Plaque Psoriasis

Treatments

Drug: Placebo
Drug: DSXS1411

Study type

Interventional

Funder types

Industry

Identifiers

NCT02413229
DSXS 1411

Details and patient eligibility

About

The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Full description

This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Enrollment

151 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or non-pregnant, non-lactating females age 12 and older.
  • Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

Exclusion criteria

  • Under 12 years of age.
  • Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
  • Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

151 participants in 2 patient groups, including a placebo group

DSXS1411
Experimental group
Description:
DSXS applied once a day for a total of 28 days.
Treatment:
Drug: DSXS1411
Placebo
Placebo Comparator group
Description:
Placebo (vehicle) applied once a day for a total of 28 days.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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