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

NCT01614743 | Completed Phase 2 Results

• 1 other identifier: ROS-INC-12
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Rosacea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks

  baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

• Patient Satisfaction

  week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

Study Arms (2)

IncobotulinumtoxinA

EXPERIMENTAL

Drug: IncobotulinumtoxinA

Placebo

PLACEBO COMPARATOR

Drug: Bacteriostatic saline

Interventions

IncobotulinumtoxinA DRUG

Experimental injection given at baseline and Week 16

IncobotulinumtoxinA

Bacteriostatic saline DRUG

Placebo at baseline, incobotulinumtoxinA at 16 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 65 years of age.
• Subjects presenting with rosacea in the cheek area.
• 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
• Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent prior to performance of any study related procedure.

You may not qualify if:

• Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
• Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
• Topical or oral rosacea treatments within the past 2 weeks.
• Subjects with a significant systemic illness or illness localized to the areas of treatment.
• Botulinum toxin to the face within the past 6 months.
• Significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure.
• Concurrent skin condition affecting area to be treated.
• Prior surgery on the area to be treated within 3 months of initial treatment or during the study.
• History or evidence of keloids or hypertrophic scarring.
• Subjects currently using aminoglycoside antibiotics, curare-like agents or other agents that might interfere with neuromuscular function.
• 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.
• Current history of chronic drug or alcohol abuse.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
• Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
• Enrollment in any active study involving the use of investigational devices or drugs.

Sponsors & Collaborators

• DeNova Research: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Links

• DeNova Research Website

MeSH Terms

Conditions

Rosacea

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The limitation of this study was a very small sample size.

Results Point of Contact

• Title: Steven H Dayan, MD
• Organization: DeNova Research

sdayan@drdayan.com

312-335-2070

Study Officials

• Steven H Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 8, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 8, 2020
• Results First Posted: September 14, 2020

Record last verified: 2020-09

Locations

US (1)