Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy
Completed · Not applicable
Conditions studied: Radiation Dermatitis, Breast Cancer
In brief
This study evaluated a mushroom extract-containing topical cosmetic formulation for skin care in women receiving radiotherapy to the breast after breast-conserving surgery. Participants were randomly assigned to use either the investigational cosmetic formulation or usual moisturizing cosmetic care. The assigned cosmetic product was applied to intact skin of the breast twice daily, beginning approximately 15 days before radiotherapy, continuing throughout the approximately 3-week radiotherapy period, and ending 1 month after radiotherapy. Participants were instructed not to apply the cosmetic product during the 3 to 4 hours before a radiotherapy session. Skin condition was assessed before use of the assigned product, at the start and end of radiotherapy, and 1 month after radiotherapy. Assessments included skin hydration, transepidermal water loss, erythema, pigmentation, dermatologic evaluation, photographs, participant-reported product experience, and adverse events. The study compared changes over time between the investigational formulation and usual cosmetic skin care.
Key facts
- Study ID
- NCT07755553
- Run by
- Hifas da Terra S.L.
- People needed
- 50
- Starts
- 2024-11-20
- Expected to finish
- 2025-10-20
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female sex.
- Age 18 to 75 years.
- Scheduled to begin breast radiotherapy following breast-conserving surgery.
You may not qualify if…
- Contraindication to radiotherapy.
- History of allergic reactions to any component of the assigned cosmetic product.
- Use of topical medications or creams on the product application area during the 7 days before starting the assigned cosmetic product.
- Hypersensitivity or sensitivity in the area scheduled for irradiation.
- Any disease or disorder that, in the investigator's opinion, could interfere with the evaluation of safety or efficacy.
- Chronic or currently active skin disease that, in the investigator's opinion, could adversely affect skin condition following radiotherapy.
- History of organ removal or organ transplantation.
- Immunodeficiency.
- Progressive febrile condition.
- Use of topical or systemic treatments that could interfere with evaluation of the assigned cosmetic product.
Where it is running
- Hospital Universitario de San Juan de Alicante — Sant Joan d'Alacant, Alicante, Spain
Full record on ClinicalTrials.gov
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