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
Condition: Rosacea
MeSH terms: Rosacea
Intervention: IncobotulinumtoxinA; Bacteriostatic saline
Intervention description: Experimental injection given at baseline and Week 16; Placebo at baseline, incobotulinumtoxinA at 16 weeks
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rosacea

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.
    

Eligibility 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.