Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Launched by SCITON · Feb 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called fractional ablative laser therapy, which aims to improve skin laxity, or loose skin. The researchers want to see how safe and effective this treatment is for people who have visible skin sagging or scars. The trial is currently recruiting participants who are between 18 and 85 years old, regardless of gender, and have a specific skin type. To join the study, participants must be willing to follow certain guidelines, including using approved birth control if they are female, and agreeing to have their treatment area photographed for educational purposes.

Participants in this trial can expect to receive the fractional ablative laser treatment and will need to attend follow-up appointments to monitor their progress. It's important to note that some individuals may not qualify for the study, especially if they have certain health conditions, have had recent cosmetic procedures, or are currently pregnant or breastfeeding. If you are interested in this trial, please consider these requirements and discuss them with your healthcare provider to see if it might be a good fit for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects aged 18-85 years
• • 2. Fitzpatrick skin type I-VI
• • 3. Has visible skin laxity in the treatment region or has a scar
• • 4. 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, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)
• • 5. Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
• • 6. Subject must be able to read, understand and sign Informed Consent Form in English
• • 7. Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions
• Exclusion Criteria:
• • 1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• • 2. Any type of prior cosmetic treatment to the target area at physicians' discretion
• • 3. History of malignant tumors in the target area.
• • 4. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
• • 5. Pregnant and/or breastfeeding (Applicable to females only)
• • 6. Having an infection, dermatitis or a rash in the treatment area.
• • 7. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
• • 8. Suffering from coagulation disorders or taking prescription anticoagulation medications.
• • 9. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• • 10. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• • 11. History of vitiligo, eczema, or psoriasis.
• • 12. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
• • 13. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• • 14. Current smoker or history of smoking within 6 months of study participation.
• • 15. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study