BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

NCT03122353 | Completed Phase 1 FDA Drug

• 1 other identifier: TOL2708C
• Study Type: interventional
• Target: 699
• Locations: 1 country
• Sites: 34

Brief Summary

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (4)

• Psoriasis Area Severity Index (PASI)

  To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.

  at Day 1, Day 28

• Physician Global Assessment (PGA)

  To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.

  at Day 1, Day 28

• Body Surface Area (BSA)

  To evaluate the total body area of skin affected by psoriasis.

  at Day 1

• Adverse Events and Serious Adverse Events

  Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis

  at Day 28

Study Arms (3)

Calcipotriene Hydrate and Betamethasone

EXPERIMENTAL

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Drug: Calcipotriene and betamethasone suspension

Taclonex

ACTIVE COMPARATOR

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Drug: Taclonex

Placebo

PLACEBO COMPARATOR

Topical suspension without active ingredient

Drug: Placebo

Interventions

Calcipotriene and betamethasone suspension DRUG

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Also known as: Calcipotriene, betamethasone

Calcipotriene Hydrate and Betamethasone

Taclonex DRUG

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

Also known as: Calcipotriene, betamethasone

Taclonex

Placebo DRUG

vehicle used as placebo

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female, at least 18 years of age.
• Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
• A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
• Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
• Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
• Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose \> 400 IU/day during the study.
• Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations.
• Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study.

You may not qualify if:

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis).
• History of hypersensitivity to any component of TEST or RLD.
• Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.

Sponsors & Collaborators

• Tolmar Inc.: lead

Study Sites (34)

Site 17

Hot Springs, Arkansas, 71913, United States

Location

Site 29

Fremont, California, 94538, United States

Location

Site 12

Los Angeles, California, 90036, United States

Location

Site 18

Sherman Oaks, California, 91403, United States

Location

Site 34

Denver, Colorado, 80220, United States

Location

Site 20

Boca Raton, Florida, 33486, United States

Location

Site 01

Brandon, Florida, 33511, United States

Location

Site 25

Coral Gables, Florida, 33134, United States

Location

Site 11

Hialeah, Florida, 33012, United States

Location

Site 26

Miami, Florida, 33126, United States

Location

Site 04

Miami, Florida, 33175, United States

Location

Site 05

Miramar, Florida, 33027, United States

Location

Site 02

Tampa, Florida, 33609, United States

Location

Site 03

Tampa, Florida, 33618, United States

Location

Site 23

Winter Park, Florida, 32792, United States

Location

Site 16

Plainfield, Indiana, 46168, United States

Location

Site 19

Olathe, Kansas, 66061, United States

Location

Site 33

Lake Charles, Louisiana, 70601, United States

Location

Site 27

Saint Joseph, Missouri, 64506, United States

Location

Site 14

Las Vegas, Nevada, 89106, United States

Location

Site 09

High Point, North Carolina, 27262, United States

Location

Site 28

Hazleton, Pennsylvania, 18201, United States

Location

Site 24

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Site 32

Johnston, Rhode Island, 02919, United States

Location

Site 07

Anderson, South Carolina, 29621, United States

Location

Site 35

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 21

Austin, Texas, 78759, United States

Location

Site 06

Dallas, Texas, 75234, United States

Location

Site 30

El Paso, Texas, 79902, United States

Location

Site 08

Murphy, Texas, 75094, United States

Location

Site 15

San Antonio, Texas, 78229, United States

Location

Site 31

San Antonio, Texas, 78229, United States

Location

Site 10

Salt Lake City, Utah, 84117, United States

Location

Site 22

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

calcipotriene; Betamethasone; betamethasone dipropionate, calcipotriol drug combination

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jim Joffrion

  Catawba Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 20, 2017
• Study Start: April 11, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)