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A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea

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ClinicalTrials.gov Identifier: NCT01614743
Recruitment Status : Unknown
Verified September 2014 by Steven H. Dayan, DeNova Research.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2012
Last Update Posted : September 16, 2014
Sponsor:
Collaborator:
Merz North America, Inc.
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research

Tracking Information
First Submitted Date  ICMJE June 4, 2012
First Posted Date  ICMJE June 8, 2012
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • Change in Rosacea [ Time Frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ]
    Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment
  • Safety [ Time Frame: baseline ]
    Rate of adverse events
  • Safety [ Time Frame: 1 week ]
    Rate of adverse events
  • Safety [ Time Frame: 4 weeks ]
    Rate of adverse events
  • Safety [ Time Frame: 12 weeks ]
    Rate of adverse events
  • Safety [ Time Frame: 16 weeks ]
    Rate of adverse events
  • Safety [ Time Frame: 17 weeks ]
    Rate of adverse events
  • Safety [ Time Frame: 20 weeks ]
    Rate of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • Change in self-esteem [ Time Frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ]
    Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS) Scale
  • Patient Satisfaction [ Time Frame: week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ]
    4-point categorical assessment of patient satisfaction with treatment
  • First Impression [ Time Frame: Baseline, 17 week, and 20 week visit ]
    Upon completion of all visits, active treatment subjects' Baseline, 17 week, and 20 week visit photographs will randomly assigned to one of three photography binders (A, B, and C). Each binder will then be evaluated by 100 blinded evaluators (300 evaluations in total).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
Official Title  ICMJE A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
Brief Summary

This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea.

The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both Physician Investigator (PI) and subject will remain blinded for the duration of the study. At the 16 week visit, control subjects will enter the rescue arm portion of the study and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE
  • Drug: IncobotulinumtoxinA
    Experimental injection given at baseline and Week 16
  • Drug: Bacteriostatic saline
    Placebo at baseline, incobotulinumtoxinA at 16 weeks
Study Arms  ICMJE
  • Experimental: IncobotulinumtoxinA
    Intervention: Drug: IncobotulinumtoxinA
  • Placebo Comparator: Placebo
    Intervention: Drug: Bacteriostatic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 7, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females between 18 and 65 years of age.
  2. Subjects presenting with rosacea in the cheek area.
  3. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  4. Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:

    • postmenopausal for at least 12 months prior to study drug administration
    • without a uterus and/or both ovaries
    • has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
    • absence of an other physical condition according to the PI's discretion
  5. Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
  6. Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Exclusion Criteria:

  1. Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
  2. Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
  3. Topical or oral rosacea treatments within the past 2 weeks.
  4. Subjects with a significant systemic illness or illness localized to the areas of treatment.
  5. Botulinum toxin to the face within the past 6 months.
  6. Significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure.
  7. Concurrent skin condition affecting area to be treated.
  8. Prior surgery on the area to be treated within 3 months of initial treatment or during the study.
  9. History or evidence of keloids or hypertrophic scarring.
  10. Subjects currently using aminoglycoside antibiotics, curare-like agents or other agents that might interfere with neuromuscular function.
  11. Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function or current facial palsy.
  12. Current history of chronic drug or alcohol abuse.
  13. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
  14. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
  15. Enrollment in any active study involving the use of investigational devices or drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01614743
Other Study ID Numbers  ICMJE ROS-INC-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven H. Dayan, DeNova Research
Study Sponsor  ICMJE DeNova Research
Collaborators  ICMJE Merz North America, Inc.
Investigators  ICMJE
Principal Investigator: Steven H Dayan, MD DeNova Research
PRS Account DeNova Research
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP