Assessment of wound healing efficacy and tolerability using CicatrylTM cream based on a suction blister model in healthy subjects.

BACKGROUND

CicatrylTM cream, a topical medical device, is indicated for the treatment of superficial wounds and small skin injuries.

OBJECTIVES

To assess the efficacy and tolerability of CicatrylTM cream by measuring the recovery of the skin barrier after inducing wounds.

MATERIALS &

METHODS

A suction blister of about 6-mm diameter was induced on the inner side of each forearm of 44 healthy subjects. Using a process of randomisation, CicatrylTM cream was then applied to one wound for a maximum duration of 14 days, while the other wound was left untreated. The primary objective was to evaluate the effect of the test product on wound healing at Day 6, by comparing treated versus untreated wound areas measured by macrophotography. Secondary objectives were to evaluate healing, cutaneous barrier restoration and subjective efficacy of the cream as well as tolerability.

RESULTS

The mean wound area (± SD) at Day 6 was significantly smaller for treated wounds compared with untreated wounds (1.76±4.71 vs 15.76±7.61 mm2; p < 0.0001). For treated wounds, wound healing between Days 1 and 6 was 1.6-fold faster compared with untreated wounds (-7.90 vs-4.79 mm2/day; p < 0.0001), and the wounds healed in approximately half the time (6.8 vs 12.2 days for untreated wounds). Cutaneous barrier restoration occurred earlier for treated wounds (Day 6 vs Day 8 for untreated wounds). The cream was well tolerated, and no serious adverse events were observed.

CONCLUSION

CicatrylTM cream improves wound healing, especially within the first six days, if applied in accordance with the manufacturer's instructions.