Clinical Trial Review

September 2015 | Volume 14 | Issue 9 | Features | 1074 | Copyright © September 2015


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The study start date was May 2015 and the estimated study completion date is August 2016. The active comparator will be an injection of calcium hydroxylapatite with triamcinolone acetate, and the placebo comparator will be a placebo injection of calcium hydroxylapatite with a placebo.
Subjects must have cutaneous and soft tissue atrophy in the dorsum of both hands, as indicated by the Merz Validated Hand Grading Scale, with a score of 2, 3, or 4. Subjects must also be planning a re-volumizing rejuvenation treatment to the dorsum area of both hands
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ONYCHOMYCOSIS

Pulsed Dye Laser Treatment of Onychomycosis

The purpose of this research is to investigate the use of the Candela V-Beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus. The hypothesis is that complete nail clearance will occur in approximately half of the patients after 3 laser treatments.
Ten patients will participate nationally, all enrolled at Jefferson. Involvement in the study will last about 8 to 12 weeks per subject, the entire study taking about 12 months to complete. Subjects must have a diagnosis of onychomycosis based on a positive fungal culture for dermatophyte and positive periodic acid schiff from toenail clippings. Excluded from the study is anyone with HIV/immunosuppression, candidal toenail infection, and prior antifungal therapy within the last 6 months; as well as anyone with a personal history of psoriasis, lichen planus, or significant photosensitivity disorder.
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CHEMICAL PEELS/MELASMA

A Pilot Study Testing Salicylic Acid Peels Vs Glycolic Acid Peels for the Treatment of Melasma

Salicylic acid and glycolic acid chemical peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer. The purpose of this study is to discover the safety and effectiveness of salicylic acid chemical peels compared with glycolic acid chemical peels for the treatment of melasma.
Participants in this study will be patients who are clinically diagnosed with at least a 2 cm x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels, and the other half of the face will receive 4 treatments of 30% salicylic acid peels, all at weeks 0, 4, 8, and 12. The follow-up visit will be at week 16. This study is a pilot study designed to determine feasibility of these procedures.
A dermatologist will blindly evaluate the treated areas of each half of the face at baseline and at the final follow-up visit (week 16), comparing the areas treated with salicylic acid chemical peels with those treated by glycolic acid chemical peels to determine the best overall cosmetic appearance.
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SCAR CARE

Survey Study for Pain Management, Wound Care, Scar Care, or Urinary Drug Testing

This is a survey study that will be given to patients who have been prescribed a topical compound for pain management, wound care, or scar care; or to patients who have been requested to do a urinary drug test (UDT) by their provider.
The initial survey for pain management, wound care, scar care, or UDT will be given to the patient by their providers during their office visit. Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by e-mail or follow-up calls from Datum Research, LLC. Data collection for this study will be derived through these surveys, and the prescription written by the provider. Primary outcome measures are changes in pain, scar care, wound care, and UDT survey results. Rahm Foundation will continue the study until sufficient information has accumulated to meet the scientific objectives of the study (ie, numeric targets or effect size); the feasibility of collecting sufficient information diminishes to unacceptable levels, poor enrollment, loss to follow-up; and/or other methods of gathering appropriate information become achievable or are deemed preferable.
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