An interventional study of Mushroom extract-containing topical cosmetic formulation and Usual moisturizing cosmetic care in Radiation Dermatitis and Breast Cancer, sponsored by Hifas da Terra S.L.. Completed at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Hifas da Terra S.L. · Not applicable, Interventional, and Supportive care
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.
This was a prospective, randomized, parallel-group study conducted in women aged 18 to 75 years who were scheduled to receive breast radiotherapy after breast-conserving surgery.
Participants were assigned to one of two groups. The investigational group used a multi-ingredient topical cosmetic formulation containing extracts of Cordyceps sinensis, Ganoderma lucidum, and Hericium erinaceus, together with moisturizing and skin-conditioning ingredients. The control group used a moisturizing cosmetic product selected from products recommended as part of routine clinical practice.
In both groups, participants applied the assigned cosmetic product topically to intact breast skin scheduled for irradiation twice daily. Application began approximately 15 days before the start of radiotherapy, continued during the approximately 3-week radiotherapy period, and continued until 1 month after completion of radiotherapy. Participants were instructed not to apply the product during the 3 to 4 hours before radiotherapy and not to use another cosmetic product on the study area during the study.
Assessments were performed at four time points: approximately 15 days before radiotherapy, at the start of radiotherapy, at the end of radiotherapy, and 1 month after radiotherapy. Skin hydration was measured using a Corneometer, transepidermal water loss was measured using a Tewameter, and erythema and pigmentation were measured using a Mexameter. Measurements were obtained from predefined areas of the irradiated breast. The study also included dermatologic assessments, clinical evaluation of skin reactions, standardized photographs, participant questionnaires, and adverse-event monitoring.
The study compared changes in skin hydration, skin barrier function, erythema, pigmentation, clinical skin reactions, and participant-reported skin comfort between the investigational cosmetic formulation and usual cosmetic skin care.
127 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 50 is close to the median of 55 across 104 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Hifas da Terra S.L. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants applied the investigational mushroom extract-containing topical cosmetic formulation to intact breast skin scheduled for irradiation twice daily. Application began approximately 15 days before radiotherapy, continued throughout the approximately 3-week radiotherapy period, and continued until 1 month after radiotherapy. Participants were instructed not to apply the formulation during the 3 to 4 hours before a radiotherapy session and not to use another cosmetic product on the study area.
Other: Mushroom extract-containing topical cosmetic formulation
Participants used a moisturizing cosmetic product selected from products recommended as part of routine clinical practice. Participants applied the product to intact breast skin scheduled for irradiation 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 product during the 3 hours before radiotherapy and not to use another cosmetic product on the study area.
Other: Usual moisturizing cosmetic care
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.
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.
Change from baseline in skin hydration
Skin hydration of the irradiated breast was measured in arbitrary units using the Corneometer® CM 825. Measurements were obtained from predefined breast regions. The outcome was the change from baseline and the trajectory of skin hydration over the study visits. Higher values indicate greater stratum corneum hydration. Changes over time were compared between the mushroom extract-containing topical cosmetic formulation and usual moisturizing cosmetic care.
Time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
Change from baseline in transepidermal water loss
Transepidermal water loss was measured at the nipple-areola complex in grams per square meter per hour (g/m²/h) using the Tewameter® TM 300. The outcome was the change from baseline and the trajectory over the study visits. Lower values indicate less water loss and better skin barrier function.
Time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
Change from baseline in skin erythema index
Erythema of the irradiated breast skin was measured in index units using the Mexameter® MX 18 at predefined breast regions. The outcome was the change from baseline and the trajectory over the study visits. Higher values indicate greater erythema.
Time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
Change from baseline in skin melanin index
Skin pigmentation of the irradiated breast was measured in melanin index units using the Mexameter® MX 18 at predefined breast regions. The outcome was the change from baseline and the trajectory over the study visits. Higher values indicate greater pigmentation.
Time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
Severity of radiation-induced skin reactions
Skin reactions in the irradiated breast were evaluated clinically and categorized as: 0, no reaction; 1, mild erythema; 2, moderate radiodermatitis; or 3, severe or mixed reaction. The distribution of severity categories was compared between the two study groups at each assessment. Higher category values indicate more severe radiation-induced skin reactions.
Time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
Participants with adverse events
Number and percentage of participants who experienced any adverse event or undesirable local skin reaction after starting the assigned cosmetic regimen. Participants reported events, and investigators evaluated their severity and relationship to the assigned cosmetic regimen.
Time frame: From the first product application, approximately 15 days before radiotherapy, through 1 month after completion of radiotherapy
Participant-reported product experience
Participants assigned to the investigational formulation completed a product-use questionnaire containing 8 numerical items scored from 1 to 5 and 1 open-comment item. A score of 1 represented the most unfavorable response or strong disagreement, and a score of 5 represented the most favorable response or strong agreement. Items assessed application comfort, absorption, post-application comfort, perceived hydration, calming of itching or stinging, perceived redness, general well-being, and overall product rating. Item-level scores were summarized; no validated total score was defined.
Time frame: End of radiotherapy, approximately Day 21, and 1 month after completion of radiotherapy
Plan to share: No — No individual participant data will be made available. The study protocol did not establish a prospective plan, repository, data dictionary, access criteria, or governance process for sharing participant-level data with external researchers. Study data will be maintained confidentially and handled in accordance with applicable data-protection requirements. Only aggregate, non-identifiable study results may be reported.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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