Raynaud Phenomenon Clinical Trial
Official title:
A Multicenter Observational Pilot Study on the Use of Tadalafil Delivra Cream in the Treatment of Raynaud's Phenomenon and Pain Associated With Digital Ulcers
A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).
To determine if the feasibility of conducting a future RCT using the chosen outcome
assessments in RP patients at 2 Rheumatology clinics.
Study Design:
Observation of patients prescribed Tadalafil-Delivra 2% (Tad-Del) for the treatment of RP
with defined feasibility objectives and data collection through efficacy and safety
assessments. Study objectives are:
- At least 70% recruitment of eligible participants.
- 100% data collection from at least 70% of all enrolled subjects.
- Estimate the standard deviation(s) of all outcome assessments.
Setting/Participants:
Patients prescribed Tad-Del will be screened for study enrollment at 2 participating
rheumatology clinics by the local research team. Participants that meet all the eligibility
criteria will be enrolled in the study as subjects. Subjects will self-administer the
medication as prescribed and return to the clinic for follow-up. Data will be collected on
outcome assessments at: baseline, 1 week and at 4 to 8 weeks of treatment.
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