Please use this identifier to cite or link to this item: http://hdl.handle.net/11434/989
Title: Clinical studies in dermatology require a post-treatment observation phase to define the impact of the intervention on the natural history of the complaint.
Epworth Authors: Sinclair, Rodney
Other Authors: Turner, G. A.
Jones, Damien
Luo, S.
Keywords: Skin Conditions
Cosmetic
Treatment Withdrawal
Regression Phase
Observation Phase
Post-treatment Period
Cosmetic Clinical Dermatology
Pharmaceutical
Moisturizers
Antidandruff Formulations
Treatments for Acne
Psoriasis Pharmacotherapies
Suboptimal
Physiological
Relapse After Treatment Cessation
Monitoring Post-Treatment Physiological
Clinical Studies
Study Protocols
Sinclair Dermatology
Department of Dermatology, Epworth HealthCare, Victoria, Australia
Head & Neck Clinical Institute, Epworth HealthCare, Victoria, Australia
Issue Date: Aug-2016
Publisher: Springer
Citation: 2016 Aug;308(6):379-87.
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.
URI: http://hdl.handle.net/11434/989
DOI: 10.1007/s00403-016-1636-9.
PubMed URL: https://www.ncbi.nlm.nih.gov/pubmed/27025208
ISSN: 0340-3696
1432-069X
Journal Title: Archives of Dermatological Research
Type: Journal Article
Affiliated Organisations: University of Melbourne, Melbourne, VIC, Australia.
Unilever Research & Development, Port Sunlight, Quarry Road East, Wirral, Merseyside, CH63 3JW, UK.
Unilever Research & Development, Shanghai, People's Republic of China
Type of Clinical Study or Trial: Review
Appears in Collections:Head & Neck
Dermatology

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