This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis. The purpose of the trial is to achieve a vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R (angiotensin II type 2 receptor) with C21.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Department of Rheumatology, Salford Royal Hospital
Manchester, Salford, United Kingdom
Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography
Area under the curve for rewarming of each finger after cold challenge as measured by thermography for 15 min
Time frame: For 15 min after cold challenge (40-55 min after IMP [investigational manufacturing product] administration)
Maximum Skin Temperature After Rewarming (MAX)
Maximum skin temperature after rewarming within 15 min after cold challenge
Time frame: For 15 min after cold challenge (40-55 min after IMP administration)
The Distal Dorsal Difference, Defined as the Difference in Temperature Between the Dorsum and the Finger (DDD)
The distal dorsal difference, defined as the difference in temperature between the dorsum and the finger (DDD), from administration of IMP until before cold challenge (0 to 40 min)
Time frame: Baseline, 10, 20, 30 and 40 min
Gradient of Rewarming in the First 2 Minutes Post-cold Challenge (GRAD)
Time frame: 2 min after cold challenge (40-42 min after IMP administration)
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Placebo as first treatment