Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

• Sponsor: Sciton (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05750901
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.6
• Patients Per Site Per Month: 68.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Skin Laxity	Device: Fractional ablative laser	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Jan 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment Arm Patients will receive fractional ablative treatment for laxity.	Device: Fractional ablative laser; Fractional ablative laser used for treatment for skin laxity and tightening

Outcome Measures

Primary Outcome Measures

1. Wrinkles [1-6 months post final treatment]

   Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanctuary Plastic Surgery	Boca Raton	Florida	United States	33431

Sponsors and Collaborators

• Sciton

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sciton
• ClinicalTrials.gov Identifier: NCT05750901
• Other Study ID Numbers: LC-001
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cutis Laxa

Study Results

No Results Posted as of Mar 2, 2023