Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

NCT05750901 | Recruiting FDA Device

• 1 other identifier: LC-001
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Wrinkles

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

  1-6 months post final treatment

Study Arms (1)

Treatment Arm

OTHER

Patients will receive fractional ablative treatment for laxity.

Device: Fractional ablative laser

Interventions

Fractional ablative laser DEVICE

Fractional ablative laser used for treatment for skin laxity and tightening

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18-85 years
• Fitzpatrick skin type I-VI
• Has visible skin laxity in the treatment region or has a scar
• 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)
• Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
• Subject must be able to read, understand and sign Informed Consent Form in English
• Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

You may not qualify if:

• Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• Any type of prior cosmetic treatment to the target area at physicians' discretion
• History of malignant tumors in the target area.
• Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
• Pregnant and/or breastfeeding (Applicable to females only)
• Having an infection, dermatitis or a rash in the treatment area.
• Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of vitiligo, eczema, or psoriasis.
• 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.
• History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• Current smoker or history of smoking within 6 months of study participation.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Sponsors & Collaborators

• Sciton: lead

Study Sites (1)

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Sciton Inc.

CONTACT

6504939155; clinicaltrials@sciton.com

Sciton Inc

CONTACT

6504939155; clinicaltrials@sciton.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 2, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)