NCT02521402 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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Keloids in various races. A review of 175 cases. Plast Reconstr Surg. 1969 Dec;44(6):564-6.
Durani P, Bayat A
Levels of evidence for the treatment of keloid disease. J Plast Reconstr Aesthet Surg. 2008;61(1):4-17. Epub 2007 Jul 19. Review.
Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG
Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5. Review.
Lee JY, Yang CC, Chao SC, Wong TW
Histopathological differential diagnosis of keloid and hypertrophic scar. Am J Dermatopathol. 2004 Oct;26(5):379-84.
Marneros AG, Norris JE, Watanabe S, Reichenberger E, Olsen BR
Genome scans provide evidence for keloid susceptibility loci on chromosomes 2q23 and 7p11. J Invest Dermatol. 2004 May;122(5):1126-32.
Smiell JM, Treadwell T, Hahn HD, Hermans MH
Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft. Wounds. 2015 Jun;27(6):158-69.
Viera MH, Vivas AC, Berman B
Update on Keloid Management: Clinical and Basic Science Advances. Adv Wound Care (New Rochelle). 2012 Oct;1(5):200-206. Review.

Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery

Details for clinical trial NCT02521402

Clinical trial NCT02521402 - References