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An Open-Label Study to Assess Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645499
Recruitment Status : Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE August 21, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE April 4, 2018
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
number of participants with adrenal suppression [ Time Frame: 84 Days ]
number of participants with adrenal suppression developed during the treatment with the study drug
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03645499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study to Assess Safety
Official Title  ICMJE An Open-Label Study to Assess the Efficacy and Potential for Adrenal Suppression Following Maximal Use Treatment With TA-102 Topical Formulations in Subjects With Plaque Psoriasis.
Brief Summary An Open-Label study to assess safety
Detailed Description An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: Topical TA-102 A
    applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
  • Drug: Topical TA-102 B
    applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
  • Drug: Topical TA-102 C
    applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
  • Drug: Topical TA-102 D
    applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
  • Drug: Topical TA-102 E
    applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: Topical TA-102 A
    A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
    Intervention: Drug: Topical TA-102 A
  • Experimental: Topical TA-102 B
    A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
    Intervention: Drug: Topical TA-102 B
  • Experimental: Topical TA-102 C
    A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
    Intervention: Drug: Topical TA-102 C
  • Experimental: Topical TA-102 D
    A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
    Intervention: Drug: Topical TA-102 D
  • Experimental: Topical TA-102 E
    A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
    Intervention: Drug: Topical TA-102 E
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 9, 2019)
88
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
72
Estimated Study Completion Date  ICMJE December 15, 2019
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
  2. Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
  3. Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.

Exclusion Criteria:

  1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
  2. History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03645499
Other Study ID Numbers  ICMJE DSTO 1723
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Natalie Yantovskiy Taro Pharmaceuticals Inc
PRS Account Taro Pharmaceuticals USA
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP