Status:
UNKNOWN
Vollure for the Correction of Atrophic Facial Scarring
Lead Sponsor:
Siperstein Dermatology
Collaborating Sponsors:
Allergan
Conditions:
Atrophic Scar
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 b...
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04519515
Start Date
November 11 2020
End Date
May 1 2023
Last Update
February 15 2022
Active Locations (1)
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1
Siperstein Dermatology Group
Boynton Beach, Florida, United States, 33472