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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research
ClinicalTrials.gov Identifier:
NCT01614743
First received: June 4, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: IncobotulinumtoxinA
Drug: Bacteriostatic saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • Change in Rosacea [ Time Frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ] [ Designated as safety issue: No ]
    Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment

  • Safety [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    Rate of adverse events

  • Safety [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Rate of adverse events

  • Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Rate of adverse events

  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Rate of adverse events

  • Safety [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Rate of adverse events

  • Safety [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
    Rate of adverse events

  • Safety [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
    Rate of adverse events


Secondary Outcome Measures:
  • Change in self-esteem [ Time Frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    4-point categorical assessment of patient satisfaction with treatment

  • First Impression [ Time Frame: Baseline, 17 week, and 20 week visit ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: November 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IncobotulinumtoxinA Drug: IncobotulinumtoxinA
Experimental injection given at baseline and Week 16
Placebo Comparator: Placebo Drug: Bacteriostatic saline
Placebo at baseline, incobotulinumtoxinA at 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614743

Locations
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
DeNova Research
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Steven H Dayan, MD DeNova Research
  More Information

Additional Information:
No publications provided

Responsible Party: Steven H. Dayan, Medical Director, DeNova Research
ClinicalTrials.gov Identifier: NCT01614743     History of Changes
Other Study ID Numbers: ROS-INC-12
Study First Received: June 4, 2012
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DeNova Research:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014