A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles

NCT02019004 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: STU83962
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (2)

• Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin

  Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is: 0: no facial wrinkles 1. mild facial wrinkles 2. moderate facial wrinkles 3. severe facial wrinkling

  At baseline and at 6 months

• Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin

  Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is: 0: no wrinkles 1. minimal wrinkles 2. mild wrinkles 3. moderate wrinkles 4. severe wrinkles

  At baseline and at 6 months

Study Arms (2)

Onabotulinum Toxin A

ACTIVE COMPARATOR

One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face.

Drug: Onabotulinum Toxin A

Incobotulinum Toxin A

ACTIVE COMPARATOR

The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face.

Drug: Incobotulinum Toxin A

Interventions

Onabotulinum Toxin A DRUG

Also known as: Botox

Onabotulinum Toxin A

Incobotulinum Toxin A DRUG

Also known as: Xeomin

Incobotulinum Toxin A

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males
• In good health
• Is 20-65 years of age
• Has static and moderate dynamic forehead/glabellar wrinkles
• Has willingness and the ability to understand and provide informed consent and communicate with the study staff

You may not qualify if:

• Pregnant or lactating
• Younger than 20 or older than 65 years of age
• Has received the following treatments in the forehead or glabellar region:
• botulinum toxin injections in the past 6 months
• ablative laser procedure in the past 6 months
• radiofrequency device treatment in the past 6 months
• ultrasound device treatment in the past 6 months
• medium to deep chemical peel in the past 6 months
• temporary soft tissue augmentation material in the area to be treated in the past year
• semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
• permanent soft tissue augmentation material in the area to be treated
• Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
• Is planning to use tretinoin or retinoic acid in the next 6 months
• Has an active infection in the forehead or glabellar region (excluding mild acne)
• Is allergic to cow's milk protein

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

onabotulinum toxin A; Botulinum Toxins, Type A; incobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: December 24, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)