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New treatment option for Skin Laxity
Official title Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
ClinicalTrials.gov ID: NCT05750901
What this study is testing
- What it's testing
- Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people 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...
- Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
You likely can't join 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.
See the full eligibility criteria
- Male or female people 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boca Raton, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boca Raton, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.