NL-OMON37703CompletedNot Applicable
VOLUMA: A prospective, obervational study of the volumising effect of open-label aesthetic use of VOLUMA in mid-face area - VOLUMA
Allergan Ltd0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Desire and willingness for correction of asymmetry or enhancement of his/her mid-face area.
- •- Be willing to undergo treatment for Volume loss in the face area
- •- Females and Males >= 30 years of age
- •- Be in good health in the opinion of the investigator
- •- Sign the Informed Consent Form prior to any study-related procedures being performed
- •- Have established a realistic treatment goal that the Investigator agrees is achievable i.e.
- •- Have realistic expectations of aesthetic results
- •- Be able to understand and comply with the study requirements and be likely to complete all regular practice visits, as assessed by the Investigator
Exclusion Criteria
- •- Have extensive tissue damage that could affect the aesthetic outcome
- •- Have a known allergy to any component of VOLUMA® with Lidocaine injections
- •- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- •- Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
- •- Have an abscess or infection at the time of treatment that in the opinion of the investigator does not make the subject eligible for the procedure
- •- Have undergone cosmetic facial[e.g., face-lift, or other surgeries which may alter the appearance of the mid face region (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or meso-therapy] anywhere in the mid face region, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.
- •NOTE: Prior treatment with hyaluronic acid (HA) fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- •- Have ever received semi-permanent fillers or permanent facial implants, e.g. calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
- •- Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to Lidocaine (or any amide-based anaesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study
- •- Be a pregnant female, lactating, or planning to become pregnant at any time during the study
- •- Be a female of childbearing potential not using a reliable means of contraception
- •- Have received any investigational product within 30 days prior to study enrolment or be planning to participate in another investigation during the course of this study
- •- Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)
- •- Have a history of or currently suffer from autoimmune disease (e.g., Rheumatoid arthritis, Crohn*s disease)
- •- Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)
- •- Have a history of skin cancer
- •- Suffer from Porphyria
- •- Have epilepsy which is not controlled by anti-epilepsy therapy
- •- Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes, etc.)
- •- Have a history of treatment with interferon for chronic hepatitis C
- •- Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day washout period
- •- Be on a concurrent regimen of high doses of Lidocaine (more than 400 mg) which may cause acute toxic reactions
- •- Be on a concurrent regimen of other local anaesthetics structurally related to amide-type local anaesthetic
Investigators
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