Efficacy of Oral Cicaglocal for Wound Healing and Pruritus Alleviation in Patients with Epidermolysis Bullosa: A Single-Arm Clinical Trial.

INTRODUCTION

Epidermolysis bullosa (EB) is a rare dermatosis causing mucocutaneous fragility, which can culminate in secondary afflictions such as contractures. This disease can adversely impact the lives of sufferers with pruritus.

OBJECTIVE

This study was conducted to assess the effects of Cicaglocal in improving wound repair and pruritus intensity in EB patients.

METHOD: This single-arm non-randomized trial was carried out in 2024 on 12 EB patients. The recruited patients administered one capsule of Cicaglocal daily for 28 days. Intensities of pruritus and pain were measured with the visual analogue scale. Also, patients' improvement was assessed utilizing clinical global impression of improvement and patient global impression of improvement. Furthermore, dimensions of ulcers were measured. These examinations were implemented on the first day, prior to the start of taking Cicaglocal, and after four weeks. We used the IBM ™ SPSS Statistics application (version 20.0) for statistical analyses.

RESULTS

Patients included six females and six males of Persian ethnicity, with an average age of 20.17 ± 11.99 years. Despite no remarkable change in the count and length of the ulcers, the width of wounds (median width: 9.5 mm to 4.5 mm, P=0.042) and magnitude of pruritus (median: 8.5 to 4.5 mm, P=0.026) exhibited a statistically significant decrease after four weeks of treatment. Moreover, three and two patients developed gastritis and esophagitis, respectively.

CONCLUSION

Cicaglocal was a relatively efficient medication for relieving pruritus and enhancing wound healing in EB patients. However, we highly recommend more studies on these issues.