NCT03127384

Brief Summary

The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_4 healthy-volunteers

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_4 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

August 26, 2022

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

April 20, 2017

Results QC Date

September 11, 2019

Last Update Submit

August 24, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek

    Overall scar severity assessed by blinded evaluator.

    Month 3

Secondary Outcomes (1)

  • Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)

    Month 1, Month 3

Study Arms (2)

No-treatment control

EXPERIMENTAL
Other: No-treatment control

Treatment

EXPERIMENTAL

Intradermal injection Restylane Lidocaine

Device: Restylane Lidocaine

Interventions

Restylane LidocaineDEVICE

Hyaluronic acid based filler

Treatment
No-treatment controlOTHER

No-treatment control

No-treatment control

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Intent to undergo treatment of depressed acne scars
  • Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area
  • Similar type, size and number of scars on both cheeks
  • Men or non-pregnant, non-breast feeding women
  • Fitzpatrick skin type I-IV
  • Signed and dated informed consent to participate in the study

You may not qualify if:

  • Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of \> 4 mm.
  • Active acne with inflammatory component
  • Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment
  • Use of isotretinoin within 6 months before treatment
  • Post-surgical scars in the treatment area
  • Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area
  • Previous tissue augmenting therapy, contouring or revitalisation treatment with Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area within 24 months before treatment
  • Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area within 12 months before treatment
  • Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment
  • Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Darmstadt

Darmstadt, Germany

Location

Munich

Munich, Germany

Location

Related Publications (1)

  • Dierickx C, Larsson MK, Blomster S. Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel. Dermatol Surg. 2018 Nov;44 Suppl 1:S10-S18. doi: 10.1097/DSS.0000000000001689.

    PMID: 30358630RESULT

Results Point of Contact

Title
Clinical Project Manager
Organization
Q-Med AB
reception.seupp@galderma.com
+46184749000

Study Officials

  • Study Director

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 25, 2017

Study Start

April 20, 2017

Primary Completion

February 15, 2018

Study Completion

November 8, 2018

Last Updated

August 26, 2022

Results First Posted

October 3, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)