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

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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.

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Abbreviations

ETN:

Etanercept

HA:

Hydroxyanisole

PASI:

Psoriasis Area and Severity Index

PASI75:

75 % Reduction in PASI score

sc:

Subcutaneous

TEWL:

Transepidermal water loss

TNF:

Tumor necrosis factor

TWHS AF:

Total weighted head score (adhered flake)

ZPT:

Zinc pyrithione

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Acknowledgments

Editorial assistance was provided by Julie Ponting of Anthemis Consulting Ltd., funded by Unilever Research & Development, Port Sunlight, UK. Dr Jane Matheson, Unilever Research & Development, Port Sunlight, provided guidance on manuscript structure.

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Authors and Affiliations

  1. Epworth Hospital, Melbourne, VIC, Australia

    Rodney Sinclair

  2. University of Melbourne, Melbourne, VIC, Australia

    Rodney Sinclair

  3. Unilever Research & Development, Port Sunlight, Quarry Road East, Wirral, Merseyside, CH63 3JW, UK

    Graham A. Turner & D. Andrew R. Jones

  4. Unilever Research & Development, Shanghai, People’s Republic of China

    Shengjun Luo

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  1. Rodney Sinclair
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  2. Graham A. Turner
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Correspondence to Graham A. Turner.

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Funding

Funding for editorial assistance was provided by Unilever Research & Development, Port Sunlight, UK.

Conflict of interest

Rodney Sinclair has acted as a paid consultant for Unilever; Graham A Turner, D Andrew R Jones, and Shengjun Luo are employees of Unilever Research & Development.

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Sinclair, R., Turner, G.A., Jones, D.A.R. et al. Clinical studies in dermatology require a post-treatment observation phase to define the impact of the intervention on the natural history of the complaint. Arch Dermatol Res 308, 379–387 (2016). https://doi.org/10.1007/s00403-016-1636-9

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