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

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.