Study to Evaluate Restylane Vital Light Using an Injector Device
|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: NCT01412190|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : November 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Aesthetics||Device: Restylane Vital Light Other: No treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Randomized, Single-centre, Intra-individual Controlled, Explorative, Safety and Efficacy Study Comparing Restylane Vital White With no Treatment in the Face, Back of the Hands and décolletage, Using an Injector Device|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Other: No treatment
One side of face, one hand and one side of the décolletage is left untreated as a control.
Active Comparator: Restylane Vital Light
Restylane Vital Light administered at 3 treatment sessions 4 weeks apart
Device: Restylane Vital Light
Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.
Other Name: Restylane skinbooster
- Elasticity [ Time Frame: 0,4,8,12,20,28,36 weeks ]To evaluate the change in elasticity from baseline for the treated and untreated side respectively.
- GEIS subject [ Time Frame: 4,8,12,20,28,36 weeks ]To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively
- GEIS blinded evaluator [ Time Frame: 12,20,28,36 weeks ]To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively,
- Skin structure [ Time Frame: 0,4,8,12,20,28,36 weeks ]To evaluate the change in skin structure from baseline for the treated and untreated side respectively.
- Subject satisfaction [ Time Frame: 0,12,20,28,36 weeks ]To evaluate subject satisfaction
- Best skin quality by blinded live evaluation [ Time Frame: 12,20,28,36 weeks ]To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation
- Adverse Events [ Time Frame: 0-36 weeks ]To evaluate the safety of Restylane Vital White during the whole study by collecting Adverse Events
- Subject diary [ Time Frame: 2 weeks after each treatment ]To evaluate the acute safety profile, i.e. treatment procedure reactions by direct questioning to subjects in a diary used daily for 2 weeks after each injection.
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): NCT01412190
|University of Hamburg|
|Hamburg, Germany, 20146|
|Principal Investigator:||Martina Kerscher, Professor||University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg|