Radiation DermatitisNCT07755553
Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy
A study testing Mushroom extract-containing topical cosmetic formulation and Usual moisturizing cosmetic care in people with Radiation Dermatitis and Breast Cancer, run by Hifas da Terra S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Radiation Dermatitis, Breast Cancer
- What is being tested?
- Mushroom extract-containing topical cosmetic formulation and Usual moisturizing cosmetic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2024to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex.
- Age 18 to 75 years.
- Scheduled to begin breast radiotherapy following breast-conserving surgery.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de San Juan De Alicante
Sant Joan d'Alacant, Alicante, 03550
About this study
Official title: Cosmetic Efficacy of a Mushroom Extract-Containing Topical Cosmetic Formulation as Supportive Skin Care During Breast Radiotherapy
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.
Read the detailed description
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.
- Conditions
- Radiation Dermatitis, Breast Cancer
- Being tested
- Mushroom extract-containing topical cosmetic formulation, Usual moisturizing cosmetic care
- Keywords
- Breast Radiotherapy, Radiation-Induced Skin Reactions, Radiation Dermatitis, Skin Hydration, Skin Barrier Function, Erythema, Topical Cosmetic Formulation, Mushroom Extracts, Supportive Skin Care
- Medical subject headings
- Radiodermatitis, Breast Neoplasms, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom extract-containing topical cosmetic formulationOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mushroom extract-containing topical cosmetic formulation | Experimental | 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. Receives: Other: Mushroom extract-containing topical cosmetic formulation |
| Usual moisturizing cosmetic care | Active comparator | 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. Receives: Other: Usual moisturizing cosmetic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of radiotherapy, approximately Day 21, and 1 month after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start20 Nov 2024
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1.5 ratio to one of two parallel groups: a topical cosmetic formulation containing mushroom extract or usual moisturizing cosmetic care. Both groups used their assigned topical cosmetic regimen from approximately 15 days before breast radiotherapy until 1 month after completion of radiotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hifas da Terra S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AITEX Centro Investigación E Innovación
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755553
- Sponsor's protocol ID
- HDT-RT-SKIN-2024-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Efficacy of a Mushroom Extract-Containing Topical Cosmetic Formulation as Supportive Skin Care During Breast Radiotherapy
- ClinicalTrials.gov ID
- NCT07755553
- Acronym / sponsor ID
- HDT-RT-SKIN-2024-01
- Conditions
- Radiation Dermatitis, Breast Cancer
- Keywords
- Breast Radiotherapy, Radiation-Induced Skin Reactions, Radiation Dermatitis, Skin Hydration, Skin Barrier Function, Erythema, Topical Cosmetic Formulation, Mushroom Extracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hifas da Terra S.L.Industry (pharma, biotech, devices)
- Collaborators
- AITEX Centro Investigación E Innovación
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1.5 ratio to one of two parallel groups: a topical cosmetic formulation containing mushroom extract or usual moisturizing cosmetic care. Both groups used their assigned topical cosmetic regimen from approximately 15 days before breast radiotherapy until 1 month after completion of radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Mushroom extract-containing topical cosmetic formulation | Experimental | Other: Mushroom extract-containing topical cosmetic formulationParticipants 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. |
| Usual moisturizing cosmetic care | Active comparator | Other: Usual moisturizing cosmetic careParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female sex.
- Age 18 to 75 years.
- Scheduled to begin breast radiotherapy following breast-conserving surgery.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mushroom extract-containing topical cosmetic formulationA 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. | Other | Mushroom extract-containing topical cosmetic formulation |
| Usual moisturizing cosmetic careA 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. | Other | Usual moisturizing cosmetic care |
Primary outcome
Change from baseline in skin hydration
Time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy
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.
6 secondary outcomes
Change from baseline in transepidermal water loss
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
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
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
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
Time frame: From the first product application, approximately 15 days before radiotherapy, through 1 month after completion of radiotherapy
Participant-reported product experience
Time frame: End of radiotherapy, approximately Day 21, and 1 month after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mushroom extract-containing topical cosmetic formulation and Usual moisturizing cosmetic care in people with Radiation Dermatitis and Breast Cancer, run by Hifas da Terra S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in skin hydration (time frame: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.