Development of Clinical Trials Outcome Instruments for Acne Vulgaris

Following the model of the OMERACT group in rheumatology, an international multi-stakeholder group of experts in evaluation of acne, care of acne patients with diverse skin phototypes, social psychology, analysis of data from acne trials, regulatory affairs, measurement of patient reported outcomes and patient representatives have been assembled and named Acne Core Outcomes Research Network (ACORN). A scientific advisory board of experts will be appointed to provide direction to ACORN initiatives. The approach will be to accomplish a series of short-term objectives that will serve as resources in acne evaluation while pursing the long-term goal to develop a “tool box” of validated outcome measures for use in acne clinical trials. At present, acne lesion counts and investigator global assessment of acne severity are the 2 major outcomes measured in regulatory trials. In addition, there is a lack of patient-reported outcomes measures of truncal acne that affects ~ half of all acne patients. Short-term objectives include: 1). Development of a web- based standardized instrument for lesion counting in acne (SILCA) to improve the variability associated with acne lesion counting; 2). Development of a comprehensive instrument to assess the impact of truncal acne on patient’s quality of life (CompAQ) and 3).Generation of pilot data on a series of four novel technologies to assess acne and/or train acne evaluators. Progress towards our long-term objective will include, reaching consensus on outcome domains and desired features of outcome measures, completion of systematic reviews of acne outcome measures of acne severity and its impact, assessment of reliability and feasibility of select global assessment scales and preliminary development of a new or revised global severity scale(s).

Contributors

PI – Professor Diane Thiboutot (US)
Co-investigators: Dr Jerry Tan (Canada), Dr Alison Layton (UK) and others

Further Study Information

Current Stage: Ongoing
Date: July 2013 - June 2016
Funding source(s): National Institute of Health


Health Area

Disease Category: Skin

Disease Name: Acne

Target Population

Age Range: 14 - 45

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Device manufacturers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Systematic review

Systematic reviews, Delphi process, method validation, new instrument construction, development of training modules, evaluation of novel technologies