Scars Clinical Trial
Official title:
Feasibility Study: Evaluation of the Ulthera® System in Combination With 70W Alma Pixel CO2 Fractional Ablative Laser for Improvement of Abdominal Striae
Verified date | January 2015 |
Source | Merz North America, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, approximately 30 minutes post-treatment, and at each follow-up visit.
Status | Completed |
Enrollment | 14 |
Est. completion date | January 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female, aged 21 to 65 years. - Subject in good health. - Fitzpatrick skin classification type 1-5. - Striae rubra and alba on the abdomen. - Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period. - Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. - Absence of physical or psychological conditions unacceptable to the investigator. - Willingness and ability to provide written consent for study-required photography and adherence to photography requirements . - Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure. - Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control during the study Exclusion Criteria: - Presence of an active systemic or local skin disease that may affect wound healing. - Current bacterial or viral infection in the area to be treated. - Severe solar elastosis. - Significant scarring or burns in area(s) to be treated. - Prior radiation therapy in the area(s) to be treated. - Open wounds or lesions in the area(s) to be treated. - History of keloid or hypertrophic scarring - History of irregular pigmentation of the skin, Lichens Planus, Vitiligo or Psoriasis in the treatment area that in the investigators opinion, would put the subject at unnecessary risk. - Inability to understand the protocol or to give informed consent. - Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within two weeks prior to study participation or during the study. - History of chronic drug or alcohol abuse. - History of autoimmune disease. - Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. - Subjects who anticipate the need for surgery or overnight hospitalization during the study. - Subjects who, in the investigator's opinion, have a history of poor cooperation,noncompliance with medical treatment, or unreliability. - Concurrent enrollment in any study involving the use of investigational devices or drugs. - Current smoker or history of smoking in the last five years. - History of prior abdominal Suction Assisted Lipectomy or Abdominoplasty. - History of prior Massive Weight Loss - History of using the following prescription medications: 1. Accutane or other systemic retinoids within the past 12 months; 2. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix); 3. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina |
United States | Art Plastic Surgery | Paramus | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Ulthera, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in overall skin texture and appearance of abdominal striae | A masked, qualitative assessment of change from baseline in the areas treated based a review of 2D images obtained at baseline and 90 days post-treatment. | 90-days post-treatment | |
Secondary | 90 Day Patient Satisfaction | Based on completion of Patient Satisfaction Questionnaires | 90 Days post-treatment | |
Secondary | 180 Day Patient Satisfaction | Based on completion of Patient Satisfaction Questionnaires | 180 Days post-treatment | |
Secondary | Change from baseline in overall aesthetic appearance of abdominal striae at 90 days | Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 90 days post-treatment based on review of pretreatment and 90 day post-treatment 2D images and a live assessment of the treatment area | 90 Days post-treatment | |
Secondary | Change from baseline in overall aesthetic appearance of abdominal striae at 180 days | Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 180 days post-treatment based on review of pretreatment and 180 day post-treatment 2D images and a live assessment of the treatment area | 180 Days post-treatment | |
Secondary | Change from baseline in skin striae texture and depth at 90 Days | Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 90 days post-treatment. | 90 Days post-treatment | |
Secondary | Change from baseline in skin striae texture and depth at 180 Days | Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 180 days post-treatment. | 180 Days post-treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04806594 -
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
|
N/A | |
Completed |
NCT01700595 -
Preexpanded Perforator Flaps in Children
|
N/A | |
Recruiting |
NCT03782038 -
Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars
|
N/A | |
Recruiting |
NCT06202274 -
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
|
N/A | |
Not yet recruiting |
NCT02590042 -
Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction
|
Phase 1 | |
Completed |
NCT01932359 -
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study
|
N/A | |
Unknown status |
NCT00969475 -
The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure
|
N/A | |
Completed |
NCT01091181 -
The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
|
N/A | |
Recruiting |
NCT06021275 -
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
|
N/A | |
Recruiting |
NCT02195063 -
Survey Study for Pain Management, Wound Care, Scar Care or UDT
|
Phase 4 | |
Terminated |
NCT00803140 -
Cutaneous Scarring of Scalpel Versus Cautery
|
N/A | |
Not yet recruiting |
NCT04593706 -
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
|
N/A | |
Recruiting |
NCT05847530 -
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
|
N/A | |
Withdrawn |
NCT01350739 -
The Umbilical Access in Laparoscopic Surgery
|
N/A | |
Completed |
NCT02145130 -
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
|
Phase 1 | |
Completed |
NCT01358838 -
Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars
|
N/A | |
Completed |
NCT03880058 -
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance
|
Phase 1/Phase 2 | |
Recruiting |
NCT05528328 -
Post-surgical Scars After the Use of CACIPLIQ20
|
Phase 3 | |
Completed |
NCT00450775 -
Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars
|
Phase 4 | |
Completed |
NCT00580736 -
Optical Clearing of the Skin in Conjunction With Laser Treatments
|
Phase 1 |