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Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars

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: NCT03127384
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy Volunteers
Interventions Device: Restylane Lidocaine
Other: No-treatment control
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Split-face: Treatment/No-treatment Control
Hide Arm/Group Description All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
Period Title: Overall Study
Started 49
Completed 3 Month Visit 47
Completed 43
Not Completed 6
Reason Not Completed
Lost to Follow-up             4
Subject request             2
Arm/Group Title Split-face: Treatment/No-treatment Control
Hide Arm/Group Description All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
40.3  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
39
  79.6%
Male
10
  20.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
48
  98.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 49 participants
49
 100.0%
1.Primary Outcome
Title Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
Hide Description Overall scar severity assessed by blinded evaluator.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Split-face: Treatment/No-treatment Control
Hide Arm/Group Description:
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81
(67 to 91)
2.Secondary Outcome
Title Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Hide Description Assessed by blinded evaluator
Time Frame Month 1, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
48 participants at Month 1, 47 participants at Month 3, due to withdrawal. Split-face design: overall 48 participants, with one treated cheek and one cheek as no-treatment control.
Arm/Group Title No-treatment Control Treatment
Hide Arm/Group Description:
No-treatment control: No-treatment control

Intradermal injection Restylane Lidocaine

Restylane Lidocaine: Hyaluronic acid based filler

Overall Number of Participants Analyzed 48 48
Overall Number of Units Analyzed
Type of Units Analyzed: Cheeks
48 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 1 Number Analyzed 48 cheeks 48 cheeks
0
(0 to 0)
96
(86 to 100)
Month 3 Number Analyzed 47 cheeks [1]  48 cheeks [1] 
6
(1 to 18)
83
(69 to 92)
[1]
47 participants
Time Frame 1 year, 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Split-face: Treatment/No-treatment Control
Hide Arm/Group Description All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
All-Cause Mortality
Split-face: Treatment/No-treatment Control
Affected / at Risk (%)
Total   0/49 (0.00%)    
Hide Serious Adverse Events
Split-face: Treatment/No-treatment Control
Affected / at Risk (%) # Events
Total   1/49 (2.04%)    
Musculoskeletal and connective tissue disorders   
Worsening of spinal disc herniation  1  1/49 (2.04%)  1
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Split-face: Treatment/No-treatment Control
Affected / at Risk (%) # Events
Total   9/49 (18.37%)    
Infections and infestations   
Influenza  1  3/49 (6.12%)  3
Nasopharyngitis  1  8/49 (16.33%)  11
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Clinical Project Manager
Organization: Q-Med AB
Phone: +46184749000
EMail: reception.seupp@galderma.com
Layout table for additonal information
Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03127384    
Other Study ID Numbers: 05DF1605
First Submitted: April 20, 2017
First Posted: April 25, 2017
Results First Submitted: September 11, 2019
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019