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OpenTrials
Completed

NCT Number: NCT01947491

A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Horizon Research Group, Inc., Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
  • Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
  • Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

Exclusion criteria

  • Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
  • Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
  • History of psoriasis unresponsive to topical treatments.
  • History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

Treatment and study plan

DFD01 Spray

Drug

Other names: Topical corticosteroid spray

Comp01 Lotion

Drug

Other names: Topical corticosteroid lotion

Vehicle Lotion

Drug

Vehicle Spray

Drug

Primary outcomes

  1. Percentage of Participants With Success According to the Investigator Global Assessment (IGA)

    Time frame: Day 15

    IGA of clear or almost clear

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Collaborators

  • Prosoft Clinical

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2013
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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