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A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Papulopustular Rosacea (PPR)

Thank you

Trial Information

A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.


Inclusion Criteria:



1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA)
score rated 3 (moderate) or 4 (severe),

2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and
pustules) on the face.

Exclusion Criteria:

1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans,
isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that
may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial
keratosis pilaris, seborrheic dermatitis, and acne,

2. The subject has rosacea with more than two nodules on the face.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Success Rate

Outcome Description:

The percentage of stubjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale. Clear= 0 No inflammatory lesions present, no erythema Almost Clear= 1 Very few small papules/pustules, very mild erythema present Mild 2= Few small papules/pustules, mild erythema Moderate 3= Several small or large papules/pustules, moderate erythema Severe 4= Numerous small and/or large papules/pustules, severe erythema

Outcome Time Frame:

Baseline to Week 12

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

RD.06.SPR.18170

NCT ID:

NCT01493687

Start Date:

December 2011

Completion Date:

August 2013

Related Keywords:

  • Papulopustular Rosacea (PPR)
  • Rosacea

Name

Location

The PolyclinicSeattle, Washington  98122
Cherry Creek Research, Inc.Denver, Colorado  80246
Center For Clinical StudiesHouston, Texas  77030
The Dermatology and Aesthetic CenterBoca Raton, Florida  33486
Derm Research, PLLCLouisville, Kentucky  40217
Dermatology Associates of Kingsport, PCKingsport, Tennessee  37660
Wake Research AssociatesRaleigh, North Carolina  27612
DermResearch, Inc.Austin, Texas  78759
Dermatology Research AssociatesLos Angeles, California  90045
Grekin Skin InstituteWarren, Michigan  48093
Progressive Clinical ResearchSan Antonio, Texas  78229
North Florida Dermatology AssociatesJacksonville, Florida  
Skin Specialists, PCOmaha, Nebraska  
Palmetto Clinical Trial Services, LLCSimpsonville, South Carolina  
MedaPhase, Inc.Newman, Georgia  30263
Dermatology Research Center, Inc.Salt Lake City, Utah  84124
The South Bend Clinic, LLPSouth Bend, Indiana  46617
Modern Research AssociatesDallas, Texas  75231
PMG Research of CharlotteCharlotte, North Carolina  28209
Central Sooner ResearchNorman, Oklahoma  73071
Dermatology Research Center of CincinnatiCincinnati, Ohio  45220
UAB Dermatology Clinical ResearchBirmingham, Alabama  35233
Northwest AR Clinical Trials CenterRogers, Arkansas  72758
University Clinical TrialsSan Diego, California  92123
Research Across AmericaSanta Ana, California  92705
The Center for Clinical & Cosmetic ResearchAventura, Florida  33180
FXM Research MiramarMiramar, Florida  33027
Laser & Skin Surgery Center of IndianaCarmel, Indiana  46032
The Indiana Clinical Trials CenterPlainfield, Indiana  46168
Lawrence Green, MD, LLCRockville, Maryland  20850
Henry Ford Health Systems Department of DermatologyDetroit, Michigan  48202
Central Dermatology PCSt. Louis, Missouri  63117
Anderson & Collins Clinical Research,Edison, New Jersey  08817
Department of Dermatology - Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Haber Dermatology Clinical Research CenterSouth Euclid, Ohio  44118
Baker Allergy, Asthma and Dermatology Research CenterLake Oswego, Oregon  97035
PMG Research of CharlestonMt. Pleasant, South Carolina  29464
TriCities Skin and CancerJohnson City, Tennessee  37604
The Education & Research Foundation, Inc.Lynchburg, Virginia  24501
PLLC dba Dermatology AssociatesSeattle, Washington  98101