Clinical Trial Review

December 2015 | Volume 14 | Issue 12 | Features | 1488 | Copyright © December 2015

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bind alpha-gal epitopes and lead to rapid activation of complement and cell lysis. The pre-existing anti-alpha-gal antibodies found in most individuals are thought to be due to exposure to alpha-gal epitopes that are naturally expressed on normal gut flora, leading to chronic immunological stimulation.
In addition to the immune checkpoint therapy, half of the patients will also receive dorgenmeltucel-L. Endpoints of the study include safety assessments, efficacy, and immunological responses.
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MELANOMA

Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma

The objective of this study is to determine the genetic profile of primary melanomas with and without synchronous regional nodal involvement by examining for (1) activating mutations BRaf and N-Ras associated with melanoma development, and (2) allelic imbalances across the genome. This study will compare the genetic profile of primary melanomas from patients with and without lymph node involvement. It will also determine the combinations of genetic lesions that correlate with nodal metastasis by adopting a statistical machine learning approach to build a lesion-based classifier for nodal metastasis.
Tumor tissue samples are collected from patients with stage I, stage II, or stage III malignant melanoma. Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using polymerase chain reaction (PCR). Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
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VITILIGO

Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo

This study is the first randomized control trial (RCT) of needling in vitiligo that uses an objective measure to quantify results.
It has the potential to establish needling as a novel, effective treatment for vitiligo, and to evaluate the use of confocal microscopy (CFM) for monitoring response to treatment.
Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin but also significant cosmetic concerns and quality of life issues. Current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment. There is a need for new, effective modalities to treat patients with otherwise refractory vitiligo.
Needling is an office-based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results.
The proposed RCT will further investigate the use of needling to treat vitiligo. It differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using CFM.
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MELASMA

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

The purpose of this study is to determine the safety and effectiveness of glycolic acid chemical peels compared with salicylic acid chemical peels for the treatment of melasma. Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). At baseline and at weeks 4, 8, and 12, 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. The follow-up visit will be at week 16. The change in best overall cosmetic appearance (right side vs left side) will be rated by a blinded dermatologist from baseline to week 16.
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