Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone

NCT01186835 | Completed

• 1 other identifier: MA-stu24810
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.

Conditions

Forehead/Glabellar Rhytid Complexes

Outcome Measures

Primary Outcomes (1)

• Measure:

  Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken.

  1 year

Secondary Outcomes (1)

• Measure: Percent Improvement

  1 year

Study Arms (2)

Combination Botulinum Toxin A and Hyaluronic Acid

EXPERIMENTAL

One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections.

Procedure: Combination Botulinum Toxin A and Hyaluronic Acid

Botulinum Toxin A alone

ACTIVE COMPARATOR

Other side of face treated with =Botulinum Toxin A injection alone.

Procedure: Botulinum Toxin A

Interventions

Combination Botulinum Toxin A and Hyaluronic Acid PROCEDURE

One side of subject's face will randomly be assigned combination treatment.

Combination Botulinum Toxin A and Hyaluronic Acid

Botulinum Toxin A PROCEDURE

Other side of subjects face with receive Botulinum Toxin A treatment alone.

Botulinum Toxin A alone

Eligibility Criteria

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

You may qualify if:

• In good health
• Is 18-65 years of age
• Has static and dynamic forehead/glabellar wrinkles
• Has willingness and the ability to understand and provide informed consent and communicate with the investigator

You may not qualify if:

• Pregnant or lactating
• 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 past year
• semi-permanent soft tissue augmentation material in the past 2 years
• permanent soft tissue augmentation material
• 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
• Is allergic to albumin

Sponsors & Collaborators

• Northwestern University: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

Alejandra Onate

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Hyaluronic Acid; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; 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: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

US (1)