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Cicatrix clinical trials

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NCT ID: NCT05478551 Active, not recruiting - Scar Clinical Trials

Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization

Start date: June 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The proposed study seeks to evaluate the scar reduction capacity of BTA on excision/biopsy wounds compared to the control (normal saline) in a double-blinded randomized control trial. It will expand upon previous studies that have already demonstrated the safety and good tolerance profile of BTA. We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control. In keeping with the results from previously conducted studies, we hypothesize that the wounds treated with BTA will have significantly less evidence of scar formation than those sites treated with normal saline.

NCT ID: NCT05239130 Active, not recruiting - Lipodystrophy Clinical Trials

Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects

Start date: March 21, 2022
Phase: N/A
Study type: Interventional

The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Auralya®) significantly decrease and / or improve their appearance, results observed after 4, 8 and 12 weeks?

NCT ID: NCT05239117 Active, not recruiting - Lipodystrophy Clinical Trials

Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

The Research Question of the present study is the following: in a population of men and women presenting dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects) will Plenhyage® significantly improve the appearance of treated areas, results observed after 4, 8 and 12 weeks?

NCT ID: NCT04915391 Active, not recruiting - Keloid Clinical Trials

Restenosis in Coronary Stents And Cutaneous HEaLing

RACHEL
Start date: April 25, 2017
Phase:
Study type: Observational

Case control study of patients with and without restenosis to demonstrate the link between in-stent restenosis and an excessive skin healing. Patients will undergo skin biopsy and blood sample tests to search for a relationship between both processes and for the identification of biomarkers and therapeutic targets.

NCT ID: NCT04756882 Active, not recruiting - Clinical trials for Hypertrophic Scarring

Clinical Evaluation of the Efficacy OF Botulinum Toxin A for Improving Facial Scars

Start date: November 18, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Scars widen when the overlying musculature pulls apart suture lines. Because Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis, the purpose of this current study is to evaluate the beneficial effects of Botulinum toxin type A (BTA) on scar formation. Aim of this study: The aim of this study is to evaluate the efficacy and safety of early postoperative Botulinum Toxin type A (BTA) injection on improving vertical or oblique facial surgical scars. Materials and methods: Patients with vertical or oblique forehead lacerations, treated by primary closure, will be enrolled in this study and randomized into two groups: One group (n =6) will receive BTA injection within 5 days of primary closure and the other group (n = 6) will receive no further treatment. Vancouver scar scale (VSS) Scores and wound width will be determined at the 1, 3 and 6 months follow-up visits, along with clinical photographs. Results: Data will be collected, tabulated and statically analyzed. Key words: Botulinum Toxin Type A; facial scarring; wound healing; scar maturation

NCT ID: NCT04456127 Active, not recruiting - Scar Clinical Trials

CO2 Laser Revision for Burn Related Donor Site Scars

Start date: January 21, 2020
Phase: N/A
Study type: Interventional

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

NCT ID: NCT04383912 Active, not recruiting - Scarring Clinical Trials

Onabotulinum Toxin A in Direct Brow Lift

Start date: November 18, 2020
Phase: N/A
Study type: Interventional

The brow lift is a surgical procedure that has been practiced for several decades. A typical indication is brow ptosis, which can be secondary to involutional changes or facial nerve palsies. Several techniques have been described, including direct, mid-forehead, coronal, and endoscopic approaches. Of these options, the direct brow lift allows for predictable post-operative brow contour and excellent control over the degree of lift achieved. As with any surgical procedure, with direct brow lift comes known undesirable post-operative outcomes, the most common of which is forehead paresthesia from supraorbital nerve damage. Other complications include alopecia and brow asymmetry. However, one of the main critiques of direct brow lift remains the poor cosmesis that can result from scarring just above the brow. A study conducted by Cho et al. concluded that of the main surgical techniques currently employed for treatment of brow ptosis, direct brow lifts held the highest rates of visible scarring. Scarring can significantly impair an individuals' quality of life. This is particularly true of facial scarring, which is often difficult to conceal. Much research has been conducted in the area of treating postoperative, traumatic, and burn-related scarring. Cadet et al completed a randomized controlled trial using topical silicone gel for direct brow lift-related scarring, given the known benefit of silicone gel sheeting for the same, but did not find a significant difference between treatment and control groups. Some effective techniques described in the literature to date include long-pulsed non-ablative Nd:YAG laser, as well as intralesional steroid injection. On the rise are studies looking into the use of botulinum toxin A for treatment of unfavourable scarring and improved facial cosmesis. Botulinum toxin is a neuromodulatory agent that has garnered usage in a variety of therapeutic and cosmetic settings. More recently, injection of botulinum toxin as a means to reduce scarring and improve outcomes in wound healing has been investigated. Several studies, including two large metaanalyses, have shown this to be an effective method of treatment. Proposed mechanisms include increased apoptosis and suppressed proliferation of fibroblasts treated with botulinum toxin, modulated via the PTEN/PI3K/Akt pathway. Park et al added to the in vitro literature by demonstrating that fibroblasts treated with botulinum toxin A produced fewer extracellular matrix proteins and pro-fibrotic factors compared to untreated cells. Another underlying mechanism that results in suboptimal wound healing is the constant contraction and relaxation of facial muscles, causing repetitive microtrauma that ultimately increases inflammation and impairs wound healing. It therefore stands to reason that by temporarily paralyzing local musculature during the post-operative period, collagen maturation can take place uninterrupted by excessive tensile forces. Despite scarring being a widely known and undesirable complication of direct brow lift surgery, there have been no studies to date examining the use of onabotulinum toxin injection to reduce said scarring and improve outcomes. With this double masked, prospective, randomized controlled trial, the investigators aim to determine whether injection of onabotulinum toxin immediately following direct brow lift surgery can improve scores on validated patient and observer scar scales.

NCT ID: NCT03901417 Active, not recruiting - Acne Scars Clinical Trials

Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Acne scarring is an unfortunate consequence of inflammatory acne vulgaris that often leads to significant cosmetic and psychosocial impacts. Although there have been many advances in the treatment of acne scarring, it remains one of the greatest challenges in cosmetic and laser dermatology. There have been a multitude of studies establishing the efficacy of non-ablative fractional laser therapy for the treatment of atrophic acne scars, and it is widely regarded as one of the best available treatments. More recently, there has been a renewed interest in controlled, non-thermal dermal injury via microneedling devices in the treatment of atrophic acne scars. Where there is a gap in the literature, however, is in the evaluation of the combination of non-ablative fractional laser resurfacing with microneedling in the treatment of atrophic acne scars. The investigators' study will compare the safety and efficacy of using non-ablative fractional laser versus a combination of microneedling and non-ablative fractional laser for atrophic acne scars using a randomized, double-blind, split-face study. The investigators' aim is to further elucidate the pathogenesis of acne scarring and the best approaches for treatment. In doing so, the investigators will study a combination approach to this complex problem in order to better serve future patients.

NCT ID: NCT03649308 Active, not recruiting - Wound Heal Clinical Trials

Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

TRUTH
Start date: September 19, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18.

NCT ID: NCT02836626 Active, not recruiting - Cesarean Section Clinical Trials

Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

Start date: June 2016
Phase: N/A
Study type: Interventional

Over 1.37 million Caesarian sections (C-sections) are performed annually in the US . It is estimated that 12-20 % of those will result in chronic scar pain. This pain can lead to functional difficulties performing activities of daily living, pain with bowel movements, and pain with sexual activity . There is anecdotal evidence supporting the use of deep fascial scar mobilization techniques in reducing abdominal surgical scar pain, and yet almost no research has been published. The aims of this randomized clinical trial will be to determine if deep fascial scar mobilization techniques or superficial scar mobilization techniques will improve chronic pain and its resulting functional deficits, threshold pressure discomfort, pressure tolerance and mobility restrictions resulting from C-section surgery and to see if these interventions are more effective than no intervention. A positive result may result in an increase in the use of this intervention and thus the reduction of chronic scar pain for many women; it may provide justification for insurance reimbursement for this approach and it will also pave the way for further investigation into the use of these techniques with other types of painful scars including hysterectomy.