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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Acne Scars Device: Restylane Vital Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Restylane Vital Lidocaine Device: Restylane Vital Lidocaine



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Assessment of Local Tolerability After Treatment [ Time Frame: 14 days ]
    Number of subjects reporting anticipated injection-related reactions after treatment

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807455


Locations
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Belgium
Skin and Laser Center
Boom, Belgium, 2850
Sponsors and Collaborators
Q-Med AB
Investigators
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Principal Investigator: Christine Dierickx, MD

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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01807455     History of Changes
Other Study ID Numbers: 05DF1206
First Posted: March 8, 2013    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes
Lidocaine
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents