Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 82 for:    acne AND Acne Scars

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Scars
Intervention Device: Restylane Vital Lidocaine
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description Restylane Vital Lidocaine
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description Restylane Vital Lidocaine
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
33
(27 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
8
  66.7%
Male
4
  33.3%
1.Primary Outcome
Title Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale
Hide Description 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.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description:
Restylane Vital Lidocaine
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
100
2.Secondary Outcome
Title Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire
Hide Description 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.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description:
Restylane Vital Lidocaine
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
83.3
3.Secondary Outcome
Title Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)
Hide Description 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.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description:
Restylane Vital Lidocaine
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
66.7
4.Secondary Outcome
Title Assessment of Local Tolerability After Treatment
Hide Description Number of subjects reporting anticipated injection-related reactions after treatment
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description:
Restylane Vital Lidocaine
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
12
5.Secondary Outcome
Title Adverse Event Reporting During the Study
Hide Description Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description:
Restylane Vital Lidocaine
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
8
Time Frame Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Restylane Vital Lidocaine
Hide Arm/Group Description Restylane Vital Lidocaine
All-Cause Mortality
Restylane Vital Lidocaine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Restylane Vital Lidocaine
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Restylane Vital Lidocaine
Affected / at Risk (%) # Events
Total   8/12 (66.67%)    
General disorders   
Implant site bruising  1  2/12 (16.67%)  2
Implant site erythema  1  5/12 (41.67%)  8
Implant site inflammation  1  1/12 (8.33%)  1
Implant site mass  1  1/12 (8.33%)  1
Implant site nodule  1  5/12 (41.67%)  9
Implant site pain  1  2/12 (16.67%)  2
Implant site swelling  1  3/12 (25.00%)  3
Injection site inflammation  1  1/12 (8.33%)  1
Injection site warmth  1  1/12 (8.33%)  1
Infections and infestations   
Nasopharyngitis  1  1/12 (8.33%)  1
Vascular disorders   
Haematoma  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Q-Med AB
Phone: + 46 (0) 18 474 90 00
Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01807455     History of Changes
Other Study ID Numbers: 05DF1206
First Submitted: March 6, 2013
First Posted: March 8, 2013
Results First Submitted: November 9, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016