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 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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: IncobotulinumtoxinA; Drug: Bacteriostatic saline

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Bacteriostatic saline; Placebo at baseline, incobotulinumtoxinA at 16 weeks
EXPERIMENTAL: IncobotulinumtoxinA	Drug: IncobotulinumtoxinA; Experimental injection given at baseline and Week 16

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in the Rosacea Clinical Score Card	Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).	baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Number of Participants Experiencing Adverse Events	Rate of adverse events	baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks	Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS) Scale. Heatherton & Polivy State Self-Esteem (HPSS) Scale includes three facets of self-esteem: Appearance, Performance, and Social The scale has a range of 20-100. A score closer to 100 signifies higher self-esteem, while a score closer to 20 signifies lower seld-esteem.	baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Patient Satisfaction	4-point categorical assessment of patient satisfaction with treatment.; Highly Satisfied- Optimal cosmetic result; Very Satisfied- Obvious improvement in appearance form the initial condition, but not completely optimal for this subject; Satisfied- Marked improvement in appearance from initial condition; Unsatisfied- The appearance is essentially the same or worse as the original condition.	week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

Collaborators and Investigators

• Sponsor: DeNova Research
• Collaborators: Merz North America, Inc.

Publications and helpful links

Helpful Links

• DeNova Research Website

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (ESTIMATE): June 8, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Rosacea
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: ROS-INC-12