An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine

NCT01807455 | Completed Phase 4 Results

• 1 other identifier: 05DF1206
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale

  Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.

  36 weeks

Secondary Outcomes (4)

• Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire

  36 weeks

• Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)

  36 weeks

• Assessment of Local Tolerability After Treatment

  14 days

• Adverse Event Reporting During the Study

  36 weeks

Study Arms (1)

Restylane Vital Lidocaine

EXPERIMENTAL

Device: Restylane Vital Lidocaine

Interventions

Restylane Vital Lidocaine DEVICE

Restylane Vital Lidocaine

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 25 to 45 years.
• Caucasian with Fitzpatrick skin type I-III.
• Must be cooperative and willing to comply with the instructions and procedures.
• Provision of signed and dated informed consent to participate in the study.
• Presence of depressed facial atrophic acne scars with a diameter of \<4 mm according to at least SCAR-S score 3 category moderate (i.e. more than half of the face involved).

You may not qualify if:

• Icepick scarring or atrophic scars with a diameter of ≥4 mm covering more than 25% of the face.
• Active acne with inflammatory component.
• Post-surgical scars in the face.
• History of keloid formation or hypertrophic scars.
• Use of isotretinoin within 12 months of the baseline visit.
• Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at a concentration above 10% or beta-hydroxy acid at a concentration above 2% or antibiotics within four months of the baseline visit.
• Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs \[NSAIDs\]), Omega-3 or vitamin E seven days before the injection, or a history of bleeding disorders.
• Use of anti-inflammatory agents seven days before the injection.
• History of radiation or skin tumours including actinic keratosis in the face.
• Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face.
• History of or active collagen diseases or autoimmune diseases such as systemic lupus erythematous, rheumatic arthritis, skin or systemic sclerosis.
• Previous hypersensitivity to HA.
• Previous hypersensitivity to lidocaine or other amide-type anaesthetics.
• Presence of facial hair that may interfere with efficacy evaluations.
• Previous tissue augmenting therapy or revitalization treatment in the treatment area with HA or collagen, within 12 months of the baseline visit.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Skin and Laser Center

Boom, 2850, Belgium

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Q-Med AB

Reception.SEUPP@galderma.com

+ 46 (0) 18 474 90 00

Study Officials

• Christine Dierickx, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 26, 2022
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

BE (1)