Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty (NCT04616898) | Clinical Trial Compass
CompletedNot Applicable
Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
United States12 participantsStarted 2020-07-01
Plain-language summary
To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.
Who can participate
Age range21 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are currently seeking abdominoplasty surgery and are consenting to their tissue that is being excised, to be tested
* Informed consent agreement signed by the subject.
* Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I-V).
* Willingness to follow the treatment and follow-up schedule and the post-treatment care.
* For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Exclusion Criteria:
* Pregnant and/or breastfeeding.
* Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
* Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after the treatment session.
* Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
* Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
* Having received collagen/fat injections or othe…
What they're measuring
1
Changes in elastin as determined by histology on biopsied tissues
Timeframe: Day 1, Day 7, Day 14, Day 20-30 post-treatment
2
Changes in collagen as determined by histology on biopsied tissues
Timeframe: Day 1, Day 7, Day 14, Day 20-30 post-treatment
3
Changes in hyaluronic acid as determined by histology on biopsied tissues
Timeframe: Day 1, Day 7, Day 14, Day 20-30 post-treatment