Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars

Healthy Volunteers Clinical Trial

Official title:

A Randomised, Evaluator-blind Comparative Study to Evaluate Performance and Safety of Restylane Lidocaine and No-treatment Control for Treatment of Depressed Facial Acne Scars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127384
• Other study ID #: 05DF1605
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2017
• Est. completion date: November 8, 2018

Study information

• Verified date: September 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 8, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Any medical condition that, in the opinion of the treating Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)

Related Conditions & MeSH terms

• Depression
• Healthy Volunteers

Intervention

Device:
• Restylane Lidocaine
Hyaluronic acid based filler

Other:
• No-treatment control
No-treatment control

Locations

Country	Name	City	State
Germany	Darmstadt	Darmstadt
Germany	Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)	Assessed by blinded evaluator	Month 1, Month 3