A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.

Phase 4

Completed

• Conditions: Rhytids
• Interventions: Drug: Restylane

• Registration Number: NCT00765583
• Lead Sponsor: Medicis Aesthetics, Inc.

Brief Summary

A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. The subjects will evaluate themselves and will also be evaluated by the treating doctor and a blinded evaluator (a person that does not know when the different sides of the face are treated). Side effects and medications taken during the study will also be recorded.

Detailed Description

The study will employ a randomized, evaluator-blind design. One of the nasolabial folds will be randomly assigned to be corrected with Restylane and then re-treated at 4 ½ months. The opposite side will be treated with Restylane and not re-treated until 9 months. Both nasolabial folds will be re-treated at 18 months. Each subject will serve as their own control, allowing comparison of the outcome between the contralateral sides.

This is a multi-center U.S. trial with a planned enrollment of 75 subjects at three centers. The goal of the study is to enroll and complete follow-up for 60 evaluable subjects. In order to compensate for early discontinuations, a total of at least 75 subjects will be recruited and treated.

After giving written informed consent, potential study participants will undergo a screening evaluation and initial treatment (Visit 1). The two nasolabial folds will be randomized for treatment so that one side will be designated for re-treatment with Restylane at 4 ½ months; the other at 9 months. At month 18 (Visit 7) both nasolabial folds will be re-treated. Follow-up visits will be scheduled through 36 months after initial treatment or touch-up.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Inclusion Criteria:

• Males or non-pregnant, non-breast feeding females aged 18 years or older.
• Subjects seeking augmentation therapy for correction of bilateral nasolabial folds.
• Subjects with a score of 3 or 4 on the Severity Rating Scale.
• Subjects with the ability to understand and comply with the requirements of the trial.
• Subjects willing to abstain from exclusionary procedures (e.g., further augmentation therapy,laser or chemical resurfacing; Botox® injections below eye level; facelift)for the duration of the study.
• Subjects willing to give written informed consent to participate in the trial.
• Women of childbearing potential must be willing to use an acceptable form of birth control during the study period.

Exclusion Criteria

• Active or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the nasolabial folds.
• Patients that have undergone procedures based on active dermal response (e.g. laser and chemical peeling procedures), within 6 months prior to study entry.
• Use of any facial tissue augmenting therapy or aesthetic facial surgical therapy within nine (9)months prior to study entry, e.g. injection or other form of implantation of tissue augmenting substances, Botox injections below the level of the eye-brows, facelift.
• Concomitant anticoagulant therapy, antiplatelet therapy, or a history of bleeding disorders.
• Patients who have previously experienced unanticipated adverse reactions when treated with hyaluronic acid based products.
• Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g., patients not likely to avoid other treatments, patients not likely to stay in the study for six months, or patients anticipated to be unreliable).
• Subjects with cancerous or pre-cancerous lesions in the area to be treated.
• Use of any investigational drugs or devices within 30 days prior to randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
restylane	Restylane	Restylane arm with different re-treatment schedules

Primary Outcome Measures

Name	Time	Method
Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18.	18 months

Secondary Outcome Measures

Name	Time	Method
Subject and Blinded Evaluator WSRS scores at all other time points and Treating Investigator and Subject Global Aesthetic Improvement Scores (GAIS) at all time points.	Through end of study

Trial Locations

Locations (3)

Dermatology Research Institute, LLC; 🇺🇸 Coral Gables, Florida, United States

Rhoda Narins, MD; 🇺🇸 White Plains, New York, United States

Dayan Facial Plastic Surgery Institute; 🇺🇸 Chicago, Illinois, United States