Treatment Trials

31 Clinical Trials for Various Conditions

Focus your search

UNKNOWN
Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars
Description

Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. There is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. This prospective study is to evaluate this claim.

Conditions
COMPLETED
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar
Description

To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.

Conditions
WITHDRAWN
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
Description

This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.

UNKNOWN
Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery
Description

The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.

Conditions
COMPLETED
Assessing and Improving Patient Knowledge About Keloid Scars (Keloids)
Description

The purpose of this study is: * to identify how knowledge about keloid scars and self-treatments differs between patients who use the Internet as a source of information and patients who do not * to determine if patients who are at a high risk of developing additional keloid scars are more or less likely to change their behavior based on an educational information talk about keloid scar prevention

Conditions
COMPLETED
Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
Description

Purpose: To compare the levels of matrix metalloproteinase-1 (MMP-1), MMP-8, MMP-13 and tissue inhibitor of metalloproteinases (TIMPs) in keloid skin tissue with normal skin in the same patient and with normal discarded skin tissue (control). The investigators aim to correlate between levels of MMPs in patients with keloid scarring in comparison with normal and discarded tissue.

Conditions
COMPLETED
A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Description

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

COMPLETED
A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars
Description

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

COMPLETED
Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars
Description

This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.

Conditions
COMPLETED
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Description

This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.

Conditions
ENROLLING_BY_INVITATION
Preoperative Silicone Ointment and Wound Healing
Description

Optimal scar healing is of great importance to patients, especially following surgery of the head and neck. This study evaluates the effectiveness of preoperative silicone ointment in wound healing in head and neck surgeries.

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.

UNKNOWN
A Substantial Equivalence Study of RD04723 and Predicate Device
Description

The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.

ACTIVE_NOT_RECRUITING
Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids
Description

The study investigates the efficacy and safety of dupilumab in the treatment of keloids

Conditions
COMPLETED
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Description

Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.

COMPLETED
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
Description

To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.

COMPLETED
"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
Description

A Phase II prospective, randomized, double-blind, placebo controlled and comparative clinical study evaluating hydrogel scar-management modalities for effective management of hyperproliferative scars and keloids. This is a double-blinded study, which means that neither the evaluating physician nor the subject will know which treatment is administered. Group selection and assignment will be made at random, with a 2 in 5 chance of receiving a market-approved therapy, and 1 in 5 chance of receiving the placebo. Subjects assigned the placebo-moisturizer will receive a standard hypoallergenic dermatological hydrating cream base. Subjects assigned the silicone gel, will receive a commercially available, active comparator.

COMPLETED
Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Description

Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.

WITHDRAWN
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Description

This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.

Conditions
COMPLETED
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Description

To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Conditions
COMPLETED
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
Description

The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.

RECRUITING
Genetic Analysis of Keloids
Description

Keloids have a strong genetic component. The goal of this study is to identify genes and regulatory elements on chromosomes that are the cause for keloids or contribute to keloid scarring.

Conditions
UNKNOWN
Keloid Radiation Registry
Description

Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid. Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause secondary cancers. The investigators also do not have a good understanding as to how effective radiation therapy is in preventing recurrence of keloid. Purposes of this study are to determine the long term safety as well as efficacy of radiation therapy when used for treatment of keloid.

Conditions
RECRUITING
Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
Description

This trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

Conditions
WITHDRAWN
Efficacy of Spray Silicone in Alteration of Burn Scar
Description

In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical trial to determine the ability of spray silicone to alter the physical characteristics of burn scar compared to a placebo.

Conditions
COMPLETED
Pain Outcomes Following Intralesional Corticosteroid Injections
Description

Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment. Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure. The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.

TERMINATED
UVA1 Light for Scleroderma and Similar Conditions
Description

The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma annulare or other similar skin conditions. This UVA1 dosing schedule has been used successfully in Germany for various skin diseases, such as the above mentioned scleroderma.

COMPLETED
Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix
Description

This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.

COMPLETED
Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
Description

The pilot study is prospective, randomized, double-blinded, with intra-subject comparisons against a vehicle control. The primary objective of this pilot study is to investigate the safety and effectiveness of a new wound care product formulated to improve healing outcome, minimize complications of impaired healing and minimize the appearance of scars. This pilot study is double-blinded, which means that neither the evaluating physician nor the subject will know which treatment is administered. Subjects' with 2 comparable excision sites will be randomly assigned to use the FS2 restorative wound care product on one excision site and a vehicle formulation of the product on the other. At the discretion of the Principal Investigator, a sutured wound may be bisected for intra-wound comparison of treatments. In all cases, after application of either vehicle or FS2, a layer of petrolatum will be applied to cover the wound site as a standard of care.

UNKNOWN
Phase 1 Study of HF-LED-RL in Fitzpatrick Skin Types I to III
Description

The goal of this study is to establish the safety of high fluence LED-RL at fluence of 480 J/cm2 and 640 J/cm2 in healthy non-Hispanic, Caucasian subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in non-Hispanic, Caucasians.