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Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy
Sponsor: Hifas da Terra S.L.
Summary
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. Participants applied the assigned cosmetic product to intact breast skin twice daily, beginning about 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.
Official title: Cosmetic Efficacy of a Mushroom Extract-Containing Topical Cosmetic Formulation as Supportive Skin Care During Breast Radiotherapy
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-11-20
Completion Date
2025-10-20
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Mushroom extract-containing topical cosmetic formulation
A multi-ingredient topical cosmetic formulation containing extracts of Cordyceps sinensis, Ganoderma lucidum, and Hericium erinaceus, together with moisturizing and skin-conditioning ingredients. Participants applied the required amount with a gentle massage to intact breast skin twice daily, beginning about 15 days before radiotherapy, continuing throughout the approximately 3-week radiotherapy period, and ending 1 month after radiotherapy. The formulation was not applied during the 3 to 4 hours before a radiotherapy session. No other cosmetic product was permitted on the study area.
Usual moisturizing cosmetic care
A nonstandardized moisturizing cosmetic product the participant selected from products recommended by the clinical staff as part of routine skin care during breast radiotherapy. Participants applied the selected product to intact breast skin twice daily, beginning about 15 days before radiotherapy, continuing throughout the approximately 3-week radiotherapy period, and ending 1 month after radiotherapy. The product was not applied during the 3 hours before a radiotherapy session. No other cosmetic product was permitted on the study area.
Locations (1)
Hospital Universitario de San Juan De Alicante
Sant Joan d'Alacant, Alicante, Spain