Clinical trial · Interventional
Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy
Cosmetic Efficacy of a Mushroom Extract-Containing Topical Cosmetic Formulation as Supportive Skin Care During Breast Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mushroom extract-containing topical cosmetic formulation | Other | — | UNRESOLVED |
| Usual moisturizing cosmetic care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mushroom extract-containing topical cosmetic formulation
- description
- Participants applied the investigational mushroom extract-containing topical cosmetic formulation to intact skin of the breast 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.
- interventionNames
- Other: Mushroom extract-containing topical cosmetic formulation
- type
- ACTIVE_COMPARATOR
- label
- Usual moisturizing cosmetic care
- description
- Participants used a moisturizing cosmetic product selected from products recommended as part of routine clinical practice. The product was applied to intact skin of the breast scheduled for irradiation 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 product during the 3 hours before radiotherapy and not to use another cosmetic product on the study area.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available