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

NCT ID: NCT01614743

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-11-30

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IncobotulinumtoxinA

Group Type: EXPERIMENTAL

IncobotulinumtoxinA

Intervention Type: DRUG

Experimental injection given at baseline and Week 16

Placebo

Group Type: PLACEBO_COMPARATOR

Bacteriostatic saline

Intervention Type: DRUG

Placebo at baseline, incobotulinumtoxinA at 16 weeks

Interventions

IncobotulinumtoxinA

Experimental injection given at baseline and Week 16

Intervention Type: DRUG

Bacteriostatic saline

Placebo at baseline, incobotulinumtoxinA at 16 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: collaborator

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Steven H. Dayan

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven H Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

DeNova Research

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Related Links

http://www.denovaresearch.com

DeNova Research Website

Other Identifiers

ROS-INC-12

Identifier Type: -

Identifier Source: org_study_id