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Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

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ClinicalTrials.gov Identifier: NCT01318733
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : January 8, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief Summary:
A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Condition or disease Intervention/treatment Phase
Rosacea Drug: CD07805/47 gel 0.5% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
Study Start Date : March 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: CD07805/47 Gel 0.5% Drug: CD07805/47 gel 0.5%
In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.




Primary Outcome Measures :
  1. Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. [ Time Frame: Over 1 year ]

    Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema

    1. / Almost clear; slight redness
    2. / Mild erythema; definite redness
    3. / Moderate erythema; marked redness
    4. / Severe erythema; fiery redness

    Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female who is at least 18 years of age or older.
  • A clinical diagnosis of facial rosacea.
  • A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
  • A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Exclusion Criteria:

  • Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
  • Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
  • Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
  • Current treatment with monoamine oxidase (MAO) inhibitors.
  • Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
  • Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318733


  Show 27 Study Locations
Sponsors and Collaborators
Galderma
Investigators
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Principal Investigator: Scott Clark, MD Longmont Clinical PC
Principal Investigator: Lesly Davidson, MD Palmetto Medical Research
Principal Investigator: Steven Davis, MD Dermatology Clinical Research Center of San Antonio
Principal Investigator: Michael Donahue, MD Wilmington Medical Research
Principal Investigator: Timothy Gardner, MD East Tennessee Medical Research
Principal Investigator: Michael Gold, MD Tennessee Clinical Research Center
Principal Investigator: Fasahat Hamzavi, MD Hamzavi Dermatology
Principal Investigator: Mark Lee, MD Progressive Clinicial Research, PA
Principal Investigator: Debra Liu, MD Piedmont Medical Research
Principal Investigator: Keith Loven, MD Rivergate Dermatology Clinical Research Center, PLLC
Principal Investigator: Michael Maloney, MD Cherry Creek Research, Inc.
Principal Investigator: Angela Moore, MD Arlington Center for Dermatology
Principal Investigator: George Murakawa, MD Dermcenter PC - Somerset Skin Centre
Principal Investigator: Catherine Pointon, MD Metrolina Medical Research
Principal Investigator: Elyse Rafal, MD DermResearch Center of NewYork, Inc.
Principal Investigator: Stephen Schleicher, MD DermDox
Principal Investigator: Joel Schlessinger, MD Skin Specialists, PC
Principal Investigator: Leonard Swinyer, MD Dermatology Research Center
Principal Investigator: Amanda Tauscher, MD Compliant Clinical Research
Principal Investigator: Gary Waterman, MD Deaconess Clinic
Principal Investigator: Jonathan Weiss, MD Gwinnett Clinical Research Center, Inc.
Principal Investigator: Morrissa Baskin, MD Wenatchee Valley Medical Center, Clinical Research Department
Principal Investigator: Steven Kempers, MD Minnesota Clinical Study Center
Principal Investigator: Ava Shamban, MD The Laser Institute for Dermatology
Principal Investigator: Harry Sharata, MD Madison Skin & Research, Inc.
Principal Investigator: Russell Mader, MD TriCities Medical Research
Principal Investigator: Girish Munavalli, MD Dermatology, Laser & Vein Specialists of the Carolinas

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01318733     History of Changes
Other Study ID Numbers: RD.06.SPR.18142
First Posted: March 18, 2011    Key Record Dates
Results First Posted: January 8, 2014
Last Update Posted: April 14, 2014
Last Verified: March 2014
Keywords provided by Galderma:
Rosacea
Additional relevant MeSH terms:
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Rosacea
Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms