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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT01372566
Eligibility Criteria:
Inclusion Criteria:
Part 1:
* Subjects of either gender (M/F), 35-60 years old.
* Subjects are in good health.
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Part 2:
* Subjects of either gender (M/F), 35-60 years old.
* Subjects are in good health.
* Bilateral cheek wrinkles "in motion" with severities of ≥ type II of Glogau photoaging classification (APPENDIX I).
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
* Subject requests cosmetic improvement of facial wrinkles.
Exclusion Criteria:
* Pregnant or lactating.
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects who have a self-reported history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or antiplatelet therapy.
* Subjects who have active skin disease or skin infection in treatment area. Subjects who have a history of hypertrophic scars and keloids.
* Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
* Subject notes that he/she is HIV positive
* Subjects with history of skin cancer or actinic keratosis
* Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
* Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
* Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
* Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.
Part 2:
* Pregnant or lactating.
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects who have a history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or anti-platelet therapy.
* Subjects who have had topical or oral tretinoin, chemical peeling, botulinum toxin injection or laser and light treatment for facial rhytides or rejuvenation within past 6 months or planning to undergo treatments as described in the next 3 months.
* Facial surgery in the lower 2/3 of the face or semi-permanent dermal fillers within 1 year prior to study enrollment
* Subjects who have history of recurrent facial or labial herpes simplex infection.
* Subjects who have active skin disease or skin infection in treatment area.
* Subjects who are allergic to lidocaine or prilocaine.
* Subjects who have a history of hypertrophic scars and keloids.
* Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
* Subject notes that he/she is HIV positive
* Subjects with history of skin cancer or actinic keratosis
* Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
* Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
* Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
* Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT01372566
Study Brief:
Protocol Section:
NCT01372566