Treatment Trials

16 Clinical Trials for Various Conditions

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COMPLETED
Mederma to Reduce Appearance of Post Surgical Scars
Description

This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\&I to Mederma Ultra Gel on the appearance of post-surgical scars.

Conditions
COMPLETED
Silicone Gel for Postsurgical Scars of the Eyelid
Description

To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

ACTIVE_NOT_RECRUITING
PDL and Fractional Photothermolysis for Postsurgical Scars
Description

This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis. Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design. The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. This study is a pilot study designed to determine feasibility of this procedure.

Conditions
COMPLETED
Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
Description

1. Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes. 2. Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which is utilized for the treatment of the erythematous and telangiectasia component of surgical scars. 3. Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser.

COMPLETED
Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy
Description

This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has not had laser therapy may be eligible to participate. The visits occur every three months for up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a lower energy treatment during the study. Subjects and raters will be blinded to which therapy level the patient receives. At each visit, the scars will be photographed and the subject will complete a questionnaire to rate the scar prior to treatment. Three physicians will evaluate the scar at each visit. One rater will evaluate the scars in person during the visit, while the other two raters will evaluate the scars using photographs after each visit. During the first three study visits, subjects will receive their assigned treatment, obtain post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other skin changes after treatment. At the third study visit, subjects will have the option to receive additional treatments or terminate their participation in the study. The fourth visit for those who continue will be a treatment visit for one group and the fifth visit will be for data collection, with no treatment offered.

COMPLETED
Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery
Description

Phase 2a, prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study. Approximately twenty subjects will be randomized 1:1 to one of two treatment arms: Arm A: 2.0 mg/cm OLX10010 biweekly (every two weeks) Arm B: 5.0 mg/cm OLX10010 biweekly (every two weeks) Each treatment arm will have approximately 10 subjects. Each subject will receive both active (OLX10010) and control (placebo) treatment post-hypertrophic scar surgery biweekly (every two weeks) for a total of six doses. Dosing will occur post-surgery on Weeks 2, 4, 6, 8, 10, and 12. Post-treatment follow-up visits will occur at Weeks 18 and 24, and a long-term follow-up visit will occur at Month 12. The Patient and Observer Scar Assessment Scale (both physician and patient scales), Stony Brook Scar Evaluation Scale, Vancouver Scar Scale, and a photograph-based visual analog scale by blinded experts will be completed prior to scar revision surgery, at Weeks 2, 8, 12, 18, and 24, and at Month 12. The overall opinion responses on the physician scales of the POSAS at Week 24 will be used for primary endpoint analysis. The total length of the linear hypertrophic scar line will be divided equally for treatment with OLX10010 and placebo, injected intradermally per centimeter (cm). The OLX10010 end and placebo end of the scar line will be separated by a 2 cm or greater distance depending on the scar length. After the Week 24 visit, all data collected will be cleaned and all data management activities will be completed. After the database is frozen/locked, the primary endpoint efficacy analysis will be completed. If at least one of the treatment arms are shown to be appropriate to reduce recurrence of hypertrophic scars, all analyses will be performed. If the efficacy analysis of Arms A and B indicate the study doses are not as effective as expected, the sponsor may decide to add a third arm (Arm C) to explore the weekly dosing regimen. See detailed summary. Subjects in all study arms will continue in the study until their Month 12 visit. After all subjects complete that visit, data are collected, and data management activities are completed, Month 12 data will be analyzed.

COMPLETED
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Description

The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.

COMPLETED
Post-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of Keloids
Description

There have been many modalities utilized in the treatment of keloids of the head and neck, however none have been universally successful. The most widely utilized non-surgical intervention is primary intralesional injection with triamcinolone (TAC) which inhibits the proliferation of fibroblasts, inhibits collagen synthesis, and increases collagenase production, or fluorouracil (5-FU), a potent inhibitor of fibroblast proliferation. Despite the abundance of studies evaluating primary intralesional injection for keloids, there are limited studies available regarding the efficacy of primary surgical excision followed by adjuvant intralesional injection. The proposed study herein would serve to improve the level of evidence and to establish the safety and efficacy of combined intralesional TAC+5FU for keloids following surgical excision.

COMPLETED
A Comparison of Scar Infiltration, Scar Deactivation, and Standard of Care for the Treatment of Chronic, Post-Surgical Pain After Cesarean Section
Description

To compare scar infiltration with 0.5-1% Lidocaine at a dose of 3 mg/kg (max dose 300 mg) or scar deactivation with acupuncture surface release technique to determine which is more effective in reducing pain in adult patients with chronic, post-surgical pain related to the site of incision after low transverse Cesarean section compared to standard of care physical therapy with the McKenzie Method.

COMPLETED
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Description

Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

Conditions
NOT_YET_RECRUITING
Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery
Description

The goal of this single-arm clinical trial is to learn about the effectiveness and safety of the X A-DERM™ mADM in promoting wound healing and improving scar formation after MMS surgery for removing BCC, SCC, or MIS lesions on the face, head, and upper limbs. The main questions it aims to answer are how well this intervention works and what is the safety profile. The primary hypothesis is that the use of X A-DERM™ will result improved wound healing and scar formation after 60 days post-procedure. Participants will undergo MMS surgery to remove BCC, SCC, or MIS lesions, and then will receive the X A-DERM™ mADM graft at the surgical site. Participants will return to the office four additional times for the clinician to collect data on their wound healing. This will involve taking pictures of the wound, conducting clinical assessments (CROs), and documenting the patient's reported outcomes (PROs).

ENROLLING_BY_INVITATION
QI: Patient Satisfaction With Facial Appearance, Scar Outcome and Quality of Life After Skin Cancer Surgery
Description

The purpose of this study is to evaluate patient satisfaction and quality of life as it relates to skin cancer surgery. This research study involves taking a one-time survey online.

Conditions
COMPLETED
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
Description

Patients will be randomized either to receive standard daily dressing or hydrocolloid dressing using a randomization generator. After closing the wound with the sutures,the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days(Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly and bandaging during this time period, which has to be re-applied daily. Patients and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.

COMPLETED
Use of Prineo in Breast Reduction Surgery
Description

This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.

TERMINATED
Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars
Description

The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.

COMPLETED
Prospective Study on Cesarean Wound Outcomes
Description

This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads. The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.