Literature DB >> 27025208

Clinical studies in dermatology require a post-treatment observation phase to define the impact of the intervention on the natural history of the complaint.

Rodney Sinclair1,2, Graham A Turner3, D Andrew R Jones4, Shengjun Luo5.   

Abstract

The use of a post-treatment period of observation or "regression phase" is common in pharmaceutical and cosmetic clinical dermatology studies. Regression phases can be incorporated into a variety of study designs, ranging from simple post-treatment observation for a defined period, as has been used for moisturizers, antidandruff formulations, and treatments for acne, to more complex randomized intermittent-treatment designs, as used in studies of psoriasis pharmacotherapies. Extensive information can be derived from a regression phase. Notably, it can provide useful data on the persistence of effect and time to relapse after treatment cessation, which are particularly relevant to skin conditions in which consumer or patient adherence to treatment is suboptimal. By incorporating a regression phase, a clinical study can more closely reflect "real-world" behavior, e.g., the switching by consumers from antidandruff to beauty shampoos. The regression phase can also help to differentiate between products that show similar effectiveness during the treatment phase, and monitoring post-treatment physiological end points can provide valuable evidence on the safety and mechanism of action of the therapy.

Entities:  

Keywords:  Cosmetic; Observation phase; Regression phase; Treatment withdrawal

Mesh:

Year:  2016        PMID: 27025208     DOI: 10.1007/s00403-016-1636-9

Source DB:  PubMed          Journal:  Arch Dermatol Res        ISSN: 0340-3696            Impact factor:   3.017


  2 in total

Review 1.  Dimethyl fumarate (DMF) vs. monoethyl fumarate (MEF) salts for the treatment of plaque psoriasis: a review of clinical data.

Authors:  Lilla Landeck; Khusru Asadullah; Adriana Amasuno; Ignasi Pau-Charles; Ulrich Mrowietz
Journal:  Arch Dermatol Res       Date:  2018-03-24       Impact factor: 3.017

2.  The diversity and abundance of fungi and bacteria on the healthy and dandruff affected human scalp.

Authors:  Sally G Grimshaw; Adrian M Smith; David S Arnold; Elaine Xu; Michael Hoptroff; Barry Murphy
Journal:  PLoS One       Date:  2019-12-18       Impact factor: 3.240

  2 in total

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