Browning, John Caleb http://orcid.org/0000-0002-3708-2252
Cartwright, Martina http://orcid.org/0000-0001-7207-2810
Thorla, Ira Jr http://orcid.org/0000-0002-8342-0793
Martin, Susan A. http://orcid.org/0000-0002-9594-5036
Olayinka-Amao, Oyebimpe http://orcid.org/0000-0003-4327-192X
Maeda-Chubachi, Tomoko http://orcid.org/0000-0002-3614-1505
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results
https://doi.org/10.1007/s40257-022-00733-9
Funding for this research was provided by:
Novan Inc.
Article History
Accepted: 27 September 2022
First Online: 26 October 2022
Declarations
:
: Novan, Inc. funded B-SIMPLE4, the qualitative analyses of the exit interviews, and manuscript development.
: John Caleb Browning and Ira Thorla Jr were study investigators and are compensated (i.e., honoraria, personal fees) advisors to Novan, Inc. Martina Cartwright and Tomoko Maeda-Chubachi are employees of and stockholders in Novan, Inc. Oyebimpe Olayinka-Amao and Susan A. Martin are employees of RTI Health Solutions, which received funding to conduct the qualitative research and manuscript development. Martina Cartwright was employed by Cassiopea Inc. at the time the study was conducted.
: The interviews were included as part of the B-SIMPLE4 clinical trial. Study approval was obtained from relevant ethics committees and institutional review boards for all 55 B-SIMPLE4 US clinical trial sites that participated in B-SIMPLE4, and the protocol was reviewed by the FDA. The study was conducted in accordance with the Declaration of Helsinki.
: Study approval was obtained from relevant ethics committees and institutional review boards for all 55 B-SIMPLE4 US clinical trial sites that participated in B-SIMPLE4, and the protocol was reviewed by the FDA. The study was conducted in accordance with the Declaration of Helsinki. Patients/caregivers voluntarily provided written informed consent/assent before screening procedures for B-SIMPLE4 were initiated. Verbal consent/assent for the interviews were confirmed before each telephone interview.
: Data will not be shared.
: Not applicable.
: TMC, SAM, and OO-A contributed to the exit interview study conception and design. Data collection and analysis were performed by SAM and OO-A. The first draft of the manuscript was written by OO-A, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.