Study to Evaluate Restylane Vital Light Using an Injector Device
|ClinicalTrials.gov Identifier: NCT01412190|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : November 27, 2012
|Condition or disease||Intervention/treatment|
|Aesthetics||Device: Restylane Vital Light Other: No treatment|
|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|
|Primary Completion Date :||July 2010|
|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.
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|