Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04841551
Eligibility Criteria:
Inclusion Criteria:The following are requirements for entry into the study:
1. Male or female, 21 years and above
2. Has mild to moderate flank fat
3. Written informed consent has been obtained
4. Written Authorization for Use and Release of Health and Research Study Information has been obtained
5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
6. Ability to follow study instructions and likely to complete all required visits
7. If the subject is a female of childbearing potential (sexually active and not sterile, surgically sterilized, or postmenopausal for at least 1 year), have a urine pregnancy test evaluated as negative within 10 days prior to enrollment, have used contraception for at least 30 days prior to enrollment, and agree to use a reliable method of contraception for the duration of the study. Pregnancies that occur during the clinical trial will be followed by the sponsor until delivery or termination.
8. Subject agrees to abstain from any treatment to the flank region including botulinum toxins, hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc for the duration of the study.
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Exclusion Criteria:
The following are criteria for exclusion from participating in the study:
1. Uncontrolled systemic disease
2. Severe cardiovascular disease
3. Known allergy or sensitivity to the study medication(s) or its components
4. Females who are pregnant, nursing, or planning a pregnancy. If a pregnancy occurs during the study the pregnancy will be followed by the sponsor until delivery or termination.
5. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
6. Previous treatment to the flanks with hyaluronic acid fillers or semi-permanent filler (i.e. Radiesse) in the past 12 months and for the duration of the study
7. Any use of permanent filler materials such as Artefill or silicone in the flanks.
8. Subjects planning a cosmetic procedure in the treatment area during the study period or with prior cosmetic procedures (i.e. surgery) in the treatment area or visible scars that may affect the evaluation.
9. Any subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease.
10. Infection or dermatoses at the injection site.
11. Evidence of recent alcohol or drug abuse.
12. Medical and/or psychiatric problems that are severe enough to interfere with the study results.
13. Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection.
14. Has hair that would interfere with evaluation and treatment of the flank area
15. Has a tendency to develop hypertrophic scarring
16. Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthestics), HA products, or Streptococcal protein.
17. Has porphyria
18. Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the flank area.
19. Subject has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04841551
Study Brief:
Protocol Section:
NCT04841551