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Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy

CompletedNA

Sponsor: Hifas da Terra S.L.

Conditions: Radiation Dermatitis, Breast Cancer

Interventions: Mushroom extract-containing topical cosmetic formulation, Usual moisturizing cosmetic care

Countries: Spain

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Female sex.
* Age 18 to 75 years.
* Scheduled to begin breast radiotherapy following breast-conserving surgery.

Exclusion Criteria:

* 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.

Locations (1)

Sant Joan d'Alacant, Alicante, Spain