Clinical Trial Review
January 2013 | Volume 12 | Issue 1 | Feature | 131 | Copyright © 2013
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
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A Phase 2 Bilateral (Split-Face) Comparison Study to Assess 2 Formulations of ELAPR Compared to Juvéderm® Ultra Plus for the Treatment of Moderate to Severe Nasolabial Folds
Sponsored by Elastagen Pty Ltd, the purpose of this study is to recruit patients presenting to the clinic for treatment of moderate to severe nasolabial folds to receive either ELAPR002b or ELAPR002d for the treatment of one nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite nasolabial fold.
The primary outcome measure is the effect of 2 formulations of ELAPR on change from baseline of the severity of the nasolabial folds against a Wrinkle Assessment Scale of nasolabial folds score at 24 weeks vs active control. The primary efficacy variable is the change in Wrinkle Assessment Scale (WAS). The values for WAS recorded at each visit will be summarized by treatment.
The secondary outcome measures are the acute safety of ELAPR, assessed by the adverse event profile, and the chronic safety of ELAPR, assessed by a serum sample collected at days 1, 29, 85, and day 169, or at the completion visit in the event of early withdrawal or early termination and stored for a maximum of 5 years for the development of an assay to measure circulating antitropoelastin antibody levels.
Male and female patients aged 25 to 65 years who are in good general health and able to provide informed consent and who have moderate to severe nasolabial folds scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale are eligible for enrollment.
Patients will be excluded who have clinically significant abnormalities of hematology or biochemistry testing; bleeding diathesis, anticoagulant drugs, thrombocytopenia, or clinically significant prolonged bleeding time; chronic use of aspirin, other nonsteroidal anti-inflammatory drugs, or other antiplatelet agents; allergy to local anesthetics; active infection at the treatment site; treatment of either nasolabial fold other than with a hyaluronic acid (HA) dermal filler and treatment with a HA dermal filler within 18 months of enrollment; any serious medical condition that, in the opinion of the investigator, would have a strong possibility of requiring systemic corticosteroid medication; are pregnant or lactating; history of keloid formation; been treated with systemic corticosteroids within the previous 12 weeks; diabetes or metabolic disorders; history of anaphylaxis or allergic reactions, including any known hypersensitivity to HA or lidocaine; sensitivity to Juvéderm Ultra Plus or Juvéderm products; or have participated in any other clinical trial 1 month before treatment and for the duration of the study.
Tunable-Dye Laser Therapy to Ameliorate Hypertrophic Scarring in Burned Children
Sponsored by Massachusetts General Hospital, this study aims to answer an important question in pediatric burn care: what are the techniques whereby tunable-dye laser neo-vessel ablation is optimally employed to ameliorate hypertrophic scars resulting from burn injuries in children? Hypertrophic scarring is considered an adverse wound-healing event that results in abnormal scar formation. This scarring process is associated with pruritus and discomfort and can interfere with function and aesthetics. Topical creams, massage, stretching, and pressure are used as standard treatments of burn scar formation. With the child serving as their own control, this study seeks to objectively measure the impact of pulse-dye laser on burn scars in children. The variables of timing of application, duration, and number of sessions will be collected.
Subjects aged 9 to 21 years with a second-degree burn with erythema and the potential for hypertrophic scarring to the thigh and or trunk are eligible for inclusion in this study. Subject must be clinically stable within 3 months of the burn injury, and the burn size must be at least 15 cm2 and able to be divided into equivalent halves (divided along line of tension). Equivalent orientation distance from mobil joint with regard to history, physical findings, proximity to tension-producing forces, and orientation is required. Subjects must be in the acute phase of burn injury, generally less than 1 year from the time of the burn injury at 2 to 3 months postburn when deemed appropriate for pressure therapy and must have been evaluated as an appropriate candidate by a surgeon involved in this study for inclusion. Subjects can be included up to 1 year postburn if referred from another treatment facility. Subjects cannot have any skin conditions that could potentially have an adverse effect on wound healing, and children/guardians or significant others must be able to speak English or Spanish and respond to study questionnaires.
Subjects will be excluded if: they are younger than 9 years, as this age group is more fragile; do not have a second-degree burn to thigh and/or trunk; have chemical burns; are at low risk for hypertrophic scarring (wounds that demonstrate fading erythema at 9 to 12 weeks and wounds that are healed at less than 3 weeks