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

NCT07755553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-10

No results posted yet for this study

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.

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.

Conditions

Interventions

OTHER

Mushroom extract-containing topical cosmetic formulation

A multi-ingredient topical cosmetic cremigel 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 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. 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.

OTHER

Usual moisturizing cosmetic care

A nonstandardized moisturizing cosmetic product selected by the participant from products recommended by the clinical staff as part of routine skin care during breast radiotherapy. Participants applied the selected product 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. The product was not applied during the 3 hours before a radiotherapy session. No other cosmetic product was permitted on the study area.

Sponsors & Collaborators

  • AITEX Centro Investigación E Innovación

    collaborator UNKNOWN

  • Hifas da Terra S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-10-20
Completion
2025-10-20

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755553 on ClinicalTrials.gov