RECRUITING

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

Official Title

Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening

Quick Facts

Study Start:2022-11-01

Study Completion:2025-01-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05750901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sciton Inc.

CONTACT

6504939155

clinicaltrials@sciton.com

Sciton Inc

CONTACT

6504939155

clinicaltrials@sciton.com

Study Locations (Sites)

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431

United States

Collaborators and Investigators

Sponsor: Sciton

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01

Study Completion Date2025-01-20

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2025-01-20

Terms related to this study

Additional Relevant MeSH Terms

Skin Laxity