An Efficacy & Safety Study Evaluating Treatment Sessions of Restylane

Clinical Trial Description

Approximately 50 female subjects shall be treated with two or three initial treatment sessions including long-term follow-up 18 months after the initial treatment regimen. Efficacy and safety to be evaluated. ;

Study Design

Related Conditions & MeSH terms

Aged Skin

See also
Status	Clinical Trial	Phase
Completed	`NCT00857610` - Retinol-induced Dermatitis in Aged Skin
Completed	`NCT00323921` - Determination of Safety and Efficacy of a Laser With Cooling for Treatment of Skin	N/A
Completed	`NCT03629405` - Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT00857610 - Retinol-induced Dermatitis in Aged Skin

Completed

NCT00323921 - Determination of Safety and Efficacy of a Laser With Cooling for Treatment of Skin

N/A

Completed

NCT03629405 - Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02403986
Study type	Interventional
Source	Galderma R&D
Contact
Status	Completed
Phase	Phase 4
Start date	April 2015
Completion date	March 30, 2017

An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms