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

NCT00765583 | Completed Phase 4

• 1 other identifier: MA-04-003
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

Rhytids

Keywords

Wrinkles (Nasolabial Folds)

Outcome Measures

Primary Outcomes (1)

• Blinded Evaluator Wrinkle Severity Rating Scale (WSRS) scores at month 18.

  18 months

Secondary Outcomes (1)

• 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

Study Arms (1)

restylane

EXPERIMENTAL

Restylane arm with different re-treatment schedules

Drug: Restylane

Interventions

Restylane DRUG

Treatment of the nasolabial folds with Restylane at Day 0/Baseline, Month 4.5, Month 9 and Month 18.

restylane

Eligibility Criteria

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

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medicis Aesthetics, Inc.: lead

Study Sites (3)

Dermatology Research Institute, LLC

Coral Gables, Florida, 33146, United States

Location

Dayan Facial Plastic Surgery Institute

Chicago, Illinois, 60611, United States

Location

Rhoda Narins, MD

White Plains, New York, 10604, United States

Location

MeSH Terms

Interventions

Restylane

Study Officials

• Fredric Brandt, MD

  Dermatology Research Institute, LLC

  PRINCIPAL INVESTIGATOR

• Steven Dayan, MD

  Steven Dayan, MD

  PRINCIPAL INVESTIGATOR

• Rhoda narins, MD

  Rhoda narins, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: November 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

US (3)