Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients

Summary

Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade \> 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

Timeline

Start

2020-06-06

Primary completion

2022-09-09

Completion

2022-10-09

Outcome

Missed primary endpoint

paper This prospective study did not meet its primary endpoint of superiority of Cicaderma® over routine practice skin care PMID 37441546 ↗

Publications

• Racadot S, Arnaud A, Schiffler C, Metzger S, Perol D, Kirova Y. Cicaderma(R) in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT. Clin Transl Radiat Oncol. 2023 Jun 1;41:100647. doi: 10.1016/j.ctro.2023.100647. eCollection 2023 Jul.

Drugs

Indications