Overview

This trial is active, not recruiting.

Condition rosacea
Treatments incobotulinumtoxina, bacteriostatic saline
Phase phase 2
Sponsor DeNova Research
Collaborator Merz Pharmaceuticals, LLC
Start date June 2012
End date April 2014
Trial size 10 participants
Trial identifier NCT01614743, ROS-INC-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
incobotulinumtoxina
Experimental injection given at baseline and Week 16
(Placebo Comparator)
bacteriostatic saline
Placebo at baseline, incobotulinumtoxinA at 16 weeks

Primary Outcomes

Measure
Change in Rosacea
time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Safety
time frame: baseline
Safety
time frame: 1 week
Safety
time frame: 4 weeks
Safety
time frame: 12 weeks
Safety
time frame: 16 weeks
Safety
time frame: 17 weeks
Safety
time frame: 20 weeks

Secondary Outcomes

Measure
Change in self-esteem
time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Patient Satisfaction
time frame: week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
First Impression
time frame: Baseline, 17 week, and 20 week visit

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
Principal investigator Steven H Dayan, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by DeNova Research.