Trial Outcomes & Findings for Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles (NCT NCT00977704)

Results Overview

To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

2-weeks

Results posted on

2013-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Perlane and Restylane Perlane and Restylane used open label to correct peri-oral wrinkles
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perlane and Restylane n=20 Participants Perlane and Restylane used open label to correct peri-oral wrinkles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	59.6 years STANDARD_DEVIATION 4.04 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-weeks

Population: Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.

To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated)

Outcome measures

Outcome measures
Measure	Restylane and Perlane n=20 Participants Single arm safety study of subjects receiving Restylane and Perlane.
Local and Systemic Adverse Events	100 percentage of participants

Adverse Events

Perlane and Restylane

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Perlane and Restylane n=20 participants at risk Perlane and Restylane used open label to correct peri-oral wrinkles
General disorders Bruising	95.0% 19/20 • Number of events 27
General disorders Tenderness	50.0% 10/20 • Number of events 20
General disorders Swelling	40.0% 8/20 • Number of events 11
General disorders Redness	20.0% 4/20 • Number of events 5
Nervous system disorders Headache	10.0% 2/20 • Number of events 2
General disorders Discomfort	5.0% 1/20 • Number of events 1

Additional Information

Head of Clinical Trials

Medicis R&D Clinical Research Department

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Researcher agree to submit to Medicis for Medicis' prior review and written approval, which approval shall not be unreasonably withheld, any written publication utilizing results or other data generated from this study at least ninety days, or, for abstracts, at least thirty days before such publication is presented or submitted for publication.
Publication restrictions are in place

Restriction type: OTHER