Cosmetic Efficacy of a Mushroom Extract-Containing Topical Cosmetic Formulation as Supportive Skin Care During Breast Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in skin hydration
研究概览
简要总结
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.
详细描述
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, the assigned cosmetic product was applied topically to intact skin of the breast 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. Dermatologic assessments, clinical evaluation of skin reactions, standardized photographs, participant questionnaires, and adverse-event monitoring were also performed.
The study was designed to compare 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and the principal investigator were aware of the assigned cosmetic regimen. Dermatologic and instrumental outcome assessments were performed by evaluators who were intended to remain unaware of treatment allocation. The same dermatologist performed the dermatologic assessments, and the same trained evaluator performed the instrumental measurements throughout the study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex.
- •Age 18 to 75 years.
- •Scheduled to begin breast radiotherapy following breast-conserving surgery.
排除标准
- •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.
研究组 & 干预措施
Mushroom extract-containing topical cosmetic formulation
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.
干预措施: Mushroom extract-containing topical cosmetic formulation (Other)
Usual moisturizing cosmetic care
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.
干预措施: Usual moisturizing cosmetic care (Other)
结局指标
主要结局
Change from baseline in skin hydration
时间窗: 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.
次要结局
- Change from baseline in transepidermal water loss(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(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(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(Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy)
- Participants with adverse events(From first product application, approximately 15 days before radiotherapy, through 1 month after completion of radiotherapy)
- Participant-reported product experience(End of radiotherapy, approximately Day 21, and 1 month after completion of radiotherapy)