Vollure for the Correction of Atrophic Facial Scarring (JVAS)

Siperstein Dermatology

Status

Unknown

Conditions

Atrophic Scar

Treatments

Device: Allergan Vollure

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04519515

JVAS002

Details and patient eligibility

About

Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.

Full description

Subjects with grades ranging from 4-55 on the Quantitative Global Scarring Grading System (QGSGS)1 will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated if optimal correction on the active intervention side has not been achieved according to the treating investigator. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. The subjects will be eligible to receive treatment with Juvéderm Vollure 90 days after their last treatment on the placebo-controlled side if they choose. In addition, at 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.

Enrollment

15 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

In good general health as evidenced by medical history
For females of reproductive potential: use of highly effective contraception and a negative urine pregnancy test at screening and all injection visits.
Score of 4-55 on a validated scarring grading system

Exclusion criteria

Subjects with allergies to hyaluronic acid filler, gram positive bacteria or lidocaine.
Subjects with auto-immune conditions
Subjects with diabetes
Subjects with a history of sever anaphylactic reactions
Subjects with cancer, or other life-threatening medical condition
Subjects taking anti---coagulants, chemotherapy, immunosuppressive agents, immunomodulatory agents, diuretics, anti---histamines, or anti---inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the first 120 days of the study.
Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery.
Subjects who had neuromodulators in the past 6 months or hyaluronic acid fillers in the previous year on the face
Subjects who at any time had surgery or more permanent fillers in the face such as Bellafill or Radiesse
Subjects with tattoos or many skin growths on the face that would obscure visualization of the scars
Subjects with a history of keloid or hypertrophic scar on the face
Subjects unwilling or unable to sit still while an injector places Juvéderm Vollure in the face
Subjects unwilling or unable to keep their head still during the photos
Subjects who are pregnant or nursing
Female subjects of child-bearing potential unable to take or use some form of birth control
Subjects with any facial bruising or swelling
Subjects with current skin infections, tumors, herpes outbreak or dermatitis on the face
Subjects using skin-irritating topical preparations, pigmenting agents (self-tanning or bleaching creams), in the past two weeks or for the first 120 days of the study on the face
Any medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employee.