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

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ClinicalTrials.gov Identifier: NCT01807455
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Tracking Information
First Submitted Date  ICMJE March 6, 2013
First Posted Date  ICMJE March 8, 2013
Results First Submitted Date  ICMJE November 9, 2015
Results First Posted Date  ICMJE January 25, 2016
Last Update Posted Date January 25, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale [ Time Frame: 36 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale [ Time Frame: 36 weeks ]
Change History Complete list of historical versions of study NCT01807455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire [ Time Frame: 36 weeks ]
    Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.
  • Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S) [ Time Frame: 36 weeks ]
    Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.
  • Assessment of Local Tolerability After Treatment [ Time Frame: 14 days ]
    Number of subjects reporting anticipated injection-related reactions after treatment
  • Adverse Event Reporting During the Study [ Time Frame: 36 weeks ]
    Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
  • Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire [ Time Frame: 36 weeks ]
  • Evaluation of acne scarring using the Scale for Acne Scar Severity [ Time Frame: 36 weeks ]
  • Assessment of Local Tolerability After Treatment [ Time Frame: 14 days ]
  • Adverse Event Reporting During the Study [ Time Frame: 36 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
Official Title  ICMJE An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
Brief Summary The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Scars
Intervention  ICMJE Device: Restylane Vital Lidocaine
Study Arms  ICMJE Experimental: Restylane Vital Lidocaine
Intervention: Device: Restylane Vital Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2013)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids within 3 months of the baseline visit. (Inhaled corticoids are not an exclusion criterion).
  • 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.
  • Permanent implant or treatment with fillers based on other material than HA or collagen in the treatment area.
  • Laser, e.g. carbon dioxide and Fraxel, dermabrasion or facial light therapy, e.g. IPL, in the treatment area within 12 months of the baseline visit.
  • Chemical peeling in the treatment area within 6 months of the baseline visit.
  • Previous surgery in the treatment area.
  • Nicotine use within 6 months before the baseline visit.
  • Pregnancy or breast feeding.
  • Participation in any other clinical study within 30 days before inclusion.
  • Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion (e.g. severe chronic disease, epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction).
  • Other condition preventing the subject from entering the study in the investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
  • Study staff or close relative of study staff (e.g. parents, children, siblings and spouse).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01807455
Other Study ID Numbers  ICMJE 05DF1206
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Q-Med AB
Study Sponsor  ICMJE Q-Med AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine Dierickx, MD
PRS Account Q-Med AB
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP