Trial Outcomes & Findings for An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine (NCT NCT01807455)

Last Updated: 2022-08-26

Results Overview

Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

36 weeks

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane Vital Lidocaine Restylane Vital Lidocaine
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane Vital Lidocaine n=12 Participants Restylane Vital Lidocaine
Age, Continuous	33 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

Outcome measures

Outcome measures
Measure	Restylane Vital Lidocaine n=12 Participants Restylane Vital Lidocaine
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale	100 percentage of participants

SECONDARY outcome

Timeframe: 36 weeks

Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.

Outcome measures

Outcome measures
Measure	Restylane Vital Lidocaine n=12 Participants Restylane Vital Lidocaine
Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire	83.3 percentage of participants

SECONDARY outcome

Timeframe: 36 weeks

Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.

Outcome measures

Outcome measures
Measure	Restylane Vital Lidocaine n=12 Participants Restylane Vital Lidocaine
Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)	66.7 percentage of participants

SECONDARY outcome

Timeframe: 14 days

Number of subjects reporting anticipated injection-related reactions after treatment

Outcome measures

Outcome measures
Measure	Restylane Vital Lidocaine n=12 Participants Restylane Vital Lidocaine
Assessment of Local Tolerability After Treatment	12 participants

SECONDARY outcome

Timeframe: 36 weeks

Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)

Outcome measures

Outcome measures
Measure	Restylane Vital Lidocaine n=12 Participants Restylane Vital Lidocaine
Adverse Event Reporting During the Study	8 participants

Adverse Events

Restylane Vital Lidocaine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Restylane Vital Lidocaine n=12 participants at risk Restylane Vital Lidocaine
General disorders Implant site bruising	16.7% 2/12 • Number of events 2 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Implant site erythema	41.7% 5/12 • Number of events 8 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Implant site inflammation	8.3% 1/12 • Number of events 1 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Implant site mass	8.3% 1/12 • Number of events 1 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Implant site nodule	41.7% 5/12 • Number of events 9 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Implant site pain	16.7% 2/12 • Number of events 2 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Implant site swelling	25.0% 3/12 • Number of events 3 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Injection site inflammation	8.3% 1/12 • Number of events 1 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
General disorders Injection site warmth	8.3% 1/12 • Number of events 1 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
Vascular disorders Haematoma	8.3% 1/12 • Number of events 1 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by study personnel or spontaneous reports from the subjects.

Additional Information

Chief Medical Officer

Q-Med AB

Phone: + 46 (0) 18 474 90 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER