Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

(V01-118A-03) A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02611349
• Other study ID #: V01-118-A-303
• Status: Recruiting
• Phase: Phase 3
• First received: September 24, 2015
• Last updated: November 23, 2015
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2015
• Source: Sadick Research Group
• Contact: Laura Donohue
• Phone: 2127727242
• Email: ldonohue[@]sadickdermatology.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the long-term safety of topical IDP-118 lotion following once daily, 8-week treatment courses in subjects with plaque psoriasis followed by intermittent as needed treatment for up to 1-year. Subjects will receive treatment courses as needed during the year to manage their plaques psoriasis with following safety endpoint evaluations being conducted.

Description:

Eligible male and female participants must be greater than or equal to 18 years old, have an area of plaque Psoriasis, and not be, or plan to be, pregnant or breast feeding during the study. Subjects must be available for at least 7 office visits during the 17 week period and be willing to comply with all study instructions. Several other restrictions and criteria may apply that the study doctor will review with you to determine if you qualify to enter the study.

The subject will be instructed on how to treat the affected areas. Subjects will be instructed to squeeze a small amount of study drug (pea-sized) onto a fingertip and then spread a thin layer of the study drug over the affected area once daily up to week 8. The in-office study visits will be approximately 2 weeks apart and include assessment of the psoriasis-affected body surface area, as well as periodic small blood draws.

This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in subjects with plaque psoriasis. This means it is not approved by the FDA, but that it can be tested in research studies like this one. IDP-118 lotion is a combination product, containing halobetasol propionate 0.01% and tazarotene 0.045%, both separately FDA approved and available for the treatment of plaque psoriasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Male or female, of any race, at least 18 years of age.

2. Freely provides both verbal and written informed consent.

3. Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation.

4. Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.

5. Has a clinical diagnosis of psoriasis.

6. Is in good general health based on the subject's medical history and a physical examination, with screening hematology and serum chemistry laboratory values within normal range or not clinically significant as determined by the investigator.

7. If female and of childbearing potential, must have negative urine and serum pregnancy tests at the Screening visit and a negative urine pregnancy test at the Baseline visit.

8. If female, is either not of childbearing potential, defined as postmenopausal for at least 12 months or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is of childbearing potential and practicing an acceptable method of birth control throughout the study.

9. Subject is willing to comply with study instructions and return to the clinic for required visits

Exclusion criteria:

1. Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.

2. Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.

3. Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.

4. Is pregnant, nursing an infant, or planning a pregnancy during the study period.

5. 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.

6. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.

7. Has used any phototherapy (including laser), photochemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within 4 weeks prior to the Baseline visit.

8. Has used immunomodulatory therapy (biologics) known to affect psoriasis within 3 months of the Baseline visit.

9. Has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 4 weeks prior to the Screening visit or is intending to have exposure during the study thought likely by the investigator to modify the subject's psoriasis.

10. Is currently using lithium or Plaquenil.

11. Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.

12. Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding the use of concomitant medications/therapies.

13. Is unable to communicate or cooperate with the investigator.

14. Has any underlying disease (e.g., uncontrolled diabetes, cardiac disease) that the investigator deems uncontrolled that poses a concern for the subject's safety while participating on the study.

15. Has a history of drug or alcohol abuse.

16. Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• IDP-118
Open-label

Locations

Country	Name	City	State
United States	Sadick Research Group	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sadick Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in safety values of topical IDP-118 lotion as measured by any adverse events experienced during the course of the studyterm use of topical IDP-118 lotion once daily for up to a year in subjects with plaque psoriasis.	local skin reactions experienced due to application of IP during study period, changes from baseline in safety values, any adverse events experienced during the course of the study.	56 weeks	No