A pilot study of dermofilm in acute radiation-induced desquamative skin reactions.
Dermofilm (Innovatec, Australia Pty Ltd) is a topical preparation containing hydrophilic and lipophilic agents that enhance the barrier functions of damaged skin. It has been assessed in a pilot study of 50 patients with desquamative skin reactions to establish whether it is a suitable candidate to test against an existing, widely used alternative in a randomized controlled trial. Symptomatic improvement, compliance and healing time were the study endpoints. Symptomatic improvement occurred in 49 patients and compliance with the prescribing instructions was uniform. The range of healing times observed at all sites was large but a relationship with the size of the initial desquamated area was noted. It is concluded that a randomized trial comparing Dermofilm with a widely used and cheaper alternative would require a multicentre effort involving approximately 400 patients (200 per arm). Other trial design considerations are discussed.
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Newcastle Mater Misericordiae Hospital, New South Wales, Australia.
Wright
S
S
Denham
J W
JW
D000208:Acute Disease; D000279:Administration, Cutaneous; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D016527:Drug Costs; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D010865:Pilot Projects; D016016:Proportional Hazards Models; D011837:Radiation-Protective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D011855:Radiodermatitis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D011878:Radiotherapy / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size; D012867:Skin / Q000187:drug effects / Q000473:pathology / Q000528:radiation effects*; D017592:Skin Care; D013997:Time Factors; D014945:Wound Healing
D003879:Dermatologic Agents; D011837:Radiation-Protective Agents