NCT02573883 - 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)

Chi CC, Kirtschig G, Baldo M, Brackenbury F, Lewis F, Wojnarowska F
Topical interventions for genital lichen sclerosus. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD008240. doi: 10.1002/14651858.CD008240.pub2. Review.
He Z, Lu C, Chren MM, Zhang Z, Li Y, Ni X, Buchtel V HA, Ryan PF, Li GZ
Development and psychometric validation of the Chinese version of Skindex-29 and Skindex-16. Health Qual Life Outcomes. 2014 Dec 24;12:190. doi: 10.1186/s12955-014-0190-4.
Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U
A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.

A Randomized Trial of Clobetasol Propionate Versus Fractionated CO2 Laser for the Treatment of Lichen Sclerosus (CuRLS)

Clinical trial NCT02573883 - References