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

NCT ID: NCT01186835

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Forehead/Glabellar Rhytid Complexes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combination Botulinum Toxin A and Hyaluronic Acid

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

Group Type EXPERIMENTAL

Combination Botulinum Toxin A and Hyaluronic Acid

Intervention Type PROCEDURE

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

Botulinum Toxin A alone

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

Group Type ACTIVE_COMPARATOR

Botulinum Toxin A

Intervention Type PROCEDURE

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

Interventions

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Combination Botulinum Toxin A and Hyaluronic Acid

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

Intervention Type PROCEDURE

Botulinum Toxin A

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Taking aminoglycoside
* Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
* Is currently using anticoagulation therapy
* Has a history of bleeding disorders
* Is unable to understand the protocol or to give informed consent
* Has a mental illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medicis Pharmaceutical Corporation

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Alejandra Onate

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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MA-stu24810

Identifier Type: -

Identifier Source: org_study_id