--- title: A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis nct_id: NCT01947491 overall_status: COMPLETED phase: PHASE3 sponsor: Primus Pharmaceuticals study_type: INTERVENTIONAL primary_condition: Psoriasis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01947491.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01947491" ct_last_update_post_date: 2024-03-07 last_seen_at: "2026-05-12T06:04:53.940Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis **NCT ID:** [NCT01947491](https://clinicaltrials.gov/study/NCT01947491) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 394 - **Lead Sponsor:** Primus Pharmaceuticals - **Collaborators:** Prosoft Clinical - **Conditions:** Psoriasis - **Start Date:** 2013-11 - **Completion Date:** 2015-01 - **CT.gov Last Update:** 2024-03-07 ## Brief Summary 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **DFD01 Spray** (EXPERIMENTAL) — DFD01 Spray twice daily for 28 days - **Vehicle Spray** (PLACEBO_COMPARATOR) — Vehicle Spray twice daily for 28 days - **Comp01 Lotion** (ACTIVE_COMPARATOR) — Comp01 Lotion twice daily for 14 days - **Vehicle Lotion** (PLACEBO_COMPARATOR) — Vehicle Lotion twice daily for 28 days ## Interventions - **DFD01 Spray** (DRUG) - **Comp01 Lotion** (DRUG) - **Vehicle Lotion** (DRUG) - **Vehicle Spray** (DRUG) ## Primary Outcomes - **Percentage of Participants With Success According to the Investigator Global Assessment (IGA)** _(time frame: Day 15)_ — IGA of clear or almost clear ## Locations (40) - Horizon Research Group, Inc., Mobile, Alabama, United States - Burke Pharmaceutical Research, Hot Springs, Arkansas, United States - California Dermatology and Clinical Research Institute, Encinitas, California, United States - Encino Research Center, Encino, California, United States - Center for Dematology Clinical Research, Inc., Fremont, California, United States - Skin Surgery Medical Group, Inc., San Diego, California, United States - Redwood Dermatology Research, Santa Rosa, California, United States - Cherry Creek Research, Inc., Denver, Colorado, United States - Colorado Medical Research Center Inc., Denver, Colorado, United States - The Savin Center, PC, New Haven, Connecticut, United States - Florida Academic Center Research and Education, Miami, Florida, United States - International Dermatology Research Inc., Miami, Florida, United States - The Indiana Clinical Trials Center, Plainfield, Indiana, United States - South Bend Clinic, LLP, South Bend, Indiana, United States - Compliant Clinical Research Inc., Olathe, Kansas, United States - Dermatology Specialists Research, Louisville, Kentucky, United States - Lawrence J. Green, MD, LLC, Rockville, Maryland, United States - David Fivenson, MD, PLC, Ann Arbor, Michigan, United States - Quality Clinical Research, Inc., Omaha, Nebraska, United States - Psoriasis Treatment Center of Central NJ, East Windsor, New Jersey, United States - Academic Dermatology Associates, Albuquerque, New Mexico, United States - Fran Cook-Bolden, MD, New York, New York, United States - DermResearch Center of New York Stony Brook Medical Park, Stony Brook, New York, United States - Zoe Diane Draelos, MD, PA, High Point, North Carolina, United States - Wake Research Associates, LLC, Raleigh, North Carolina, United States - PMG Research of Winston-Salem, Winston-Salem, North Carolina, United States - Haber Dermatology & Cosmetic Surgery, Inc., South Euclid, Ohio, United States - Carolina Dermatology of Greenville, PA, Greenville, South Carolina, United States - Coastal Carolina Research Center, Mt. Pleasant, South Carolina, United States - Rivergate Dermatology Clinical Research Center, PLLC, Goodlettsville, Tennessee, United States - Tennessee Clinical Research Center, Nashville, Tennessee, United States - DermResearch, Inc., Austin, Texas, United States - J & S Studies, Inc., College Station, Texas, United States - The Center for Skin Research, Houston, Texas, United States - Stephen Miller, MD, PA, San Antonio, Texas, United States - Center for Clinical Studies, Webster, Texas, United States - Dermatology Research Center, Inc., Salt Lake City, Utah, United States - The Education & Research Foundation, Inc., Lynchburg, Virginia, United States - Virginia Clinical Research, Inc., Norfolk, Virginia, United States - Premier Clinical Research, Spokane, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.horizon research group, inc.|mobile|alabama|united states` — added _(2026-05-12)_ - `locations.burke pharmaceutical research|hot springs|arkansas|united states` — added _(2026-05-12)_ - `locations.california dermatology and clinical research institute|encinitas|california|united states` — added _(2026-05-12)_ - `locations.encino research center|encino|california|united states` — added _(2026-05-12)_ - `locations.center for dematology clinical research, inc.|fremont|california|united states` — added _(2026-05-12)_ - `locations.skin surgery medical group, inc.|san diego|california|united states` — added _(2026-05-12)_ - `locations.redwood dermatology research|santa rosa|california|united states` — added _(2026-05-12)_ - `locations.cherry creek research, inc.|denver|colorado|united states` — added _(2026-05-12)_ - `locations.colorado medical research center inc.|denver|colorado|united states` — added _(2026-05-12)_ - `locations.the savin center, pc|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.florida academic center research and education|miami|florida|united states` — added _(2026-05-12)_ - `locations.international dermatology research inc.|miami|florida|united states` — added _(2026-05-12)_ - `locations.the indiana clinical trials center|plainfield|indiana|united states` — added _(2026-05-12)_ - `locations.south bend clinic, llp|south bend|indiana|united states` — added _(2026-05-12)_ - `locations.compliant clinical research inc.|olathe|kansas|united states` — added _(2026-05-12)_ - `locations.dermatology specialists research|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.lawrence j. green, md, llc|rockville|maryland|united states` — added _(2026-05-12)_ - `locations.david fivenson, md, plc|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.quality clinical research, inc.|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.psoriasis treatment center of central nj|east windsor|new jersey|united states` — added _(2026-05-12)_ - `locations.academic dermatology associates|albuquerque|new mexico|united states` — added _(2026-05-12)_ - `locations.fran cook-bolden, md|new york|new york|united states` — added _(2026-05-12)_ - `locations.dermresearch center of new york stony brook medical park|stony brook|new york|united states` — added _(2026-05-12)_ - `locations.zoe diane draelos, md, pa|high point|north carolina|united states` — added _(2026-05-12)_ - `locations.wake research associates, llc|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.pmg research of winston-salem|winston-salem|north carolina|united states` — added _(2026-05-12)_ - `locations.haber dermatology & cosmetic surgery, inc.|south euclid|ohio|united states` — added _(2026-05-12)_ - `locations.carolina dermatology of greenville, pa|greenville|south carolina|united states` — added _(2026-05-12)_ - `locations.coastal carolina research center|mt. pleasant|south carolina|united states` — added _(2026-05-12)_ - `locations.rivergate dermatology clinical research center, pllc|goodlettsville|tennessee|united states` — added _(2026-05-12)_ - `locations.tennessee clinical research center|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.dermresearch, inc.|austin|texas|united states` — added _(2026-05-12)_ - `locations.j & s studies, inc.|college station|texas|united states` — added _(2026-05-12)_ - `locations.the center for skin research|houston|texas|united states` — added _(2026-05-12)_ - `locations.stephen miller, md, pa|san antonio|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01947491.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01947491* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*