Timeline
Subjects who are randomized to treatment will have how many treatment visits?
3. One at Week 1 (Visit 2a), Week 4 (Visit 3a), and visit 8 (Visit 4a)
Subjects must be non-pregnant, non-breasting feeding females over the age of ___
21
An irregular mammogram, with an abnormality consistent with a potential breast tumor, in the last ___ months is exclusionary
12 months
True or false: There is no emergency unblinding for this study
True! Since the PI isn't blinded, the BE would never need to be unblinded
Topical lidocaine will be applied before treatment (at least 10 mins). There is also lidocaine in the filler itself
At which visits should pregnancy tests be performed?
Visit 1, 2a (Week 1 Tx 1), 3a (Week 4 Tx 2), 4a (Week 8 Tx 3)
Can family of CCSD staff participate in this study?
No. Subjects cannot be study staff, employees of study site, or any close relatives
True or false: anticoagulants (bloodthinners), like aspirin, NSAIDs, Omega-3, and Vitamin E should be stopped 2 weeks before each filler treatment
True. Otherwise they are acceptable. Subjects should be encouraged to use acetaminophen (Tylenol)
What is considered a clinically significant change in a subject's Snellen test?
two or more line changes
True or false: subjects who are randomized to the no treatment group will have an opportunity to receive treatment later in the study
False. They will have fewer visits, but will still participate for about 8 months and cannot have any other txs to the decolletage during that time
When and for how long will subject diaries be completed?
After each treatment for 28 days
True or false: strict abstinence and barrier methods are acceptable forms of birth control for this study
Yes
In what circumstances are history of cancer or chemo treatment exclusionary?
ANY personal or family history of breast cancer. Chemo (and any other immunosuppressive therapies) within the last 3 months.
The Investigator must report any SAE to the CRO no later than ___ hours after awareness of the event. The PI shall also report the SAE to ____
24 hours. Can be done via email OR eCRF. SAE report should also be provided to IRB 'without undue delay'
According to the sponsor-provided FST scale, a subject who identifies as African American or black would be considered skin type ___
VI - their scale is different than what our office uses
Approximately how long will participation be for control and treated subjects?
32 weeks (about 8 months) for control group, 56 weeks (13 months) for treatment group
Subjects will be randomized in a __:__ ratio to receive treatment vs no treatment
3:1 (after accounting for 10% subject drop-outs)
Personal or family history of ANY severe allergies or multiple allergies is exclusionary - What constitutes a severe allergy?
Anaphylaxis or angioedema (Swelling, often around lips or eyes. Can happen on its own or along with hives)
Enrollment in the study will be temporarily halted if the sponsor is notified of what kind of SAE?
If the sponsor concludes there is a direct or possible link to the IP or procedure and the following SAE: pneumothorax (collapsed lung), a vascular embolic event, skin necrosis, vision loss or stroke
What is the maximum amount of mLs to be administered per treatment?
3 mLs per visits. 9 mLs total
What is the approximate total time from First Subject First Visit to Last Subject Last Visit?
24 months. They are allowing 12 weeks for recruitment
True or false: Subjects must consent to having photos including their face taken at each visit
False. Subjects must consent to photography, but it will be from the chin to lower chest only
A known disease or medical condition that would expose subject to 'undue risk' is exclusionary - give two examples
any autoimmune disease (MS, Graves' disease, lupus, rheumatoid arthritis), HIV, active hepatitis, any active skin disease in the treatment area
What are the assessments that must be completed by the treating investigator prior to and 30 mins after treatments?
Two chest exams - pulmonary auscultation and percussion (for hyperresonance) and three visual exams - Snellen, extraocular muscle function, and confrontation visual field
In Stage 2, up to 14 subjects who are FST V and VI won't be randomized, but will be automatically be included in the _______ and assessed for _____
Treatment Group, Safety. This means they do not have to meet the Galderma Décolletage Scale criterion