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NCT06040983
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
NA trial testing FR-101 Chest Dressing in Breast Cancer in 30 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | China Medical University Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 30 |
| Start date | 18 September 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
Drugs / interventions tested
- FR-101 Chest Dressing
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Radiation Dermatitis — all drugs for Radiation Dermatitis →
Sponsor
China Medical University Hospital
Who can join
20 and older, any sex, with Breast Cancer or Radiation Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment, and the radiation dermatitis is the major side effect affected quality of life. Radiation dermatitis can be divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life of patients during the course of treatment, and may cause treatment interruption and affect the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to so-called "radiation-irritated skin" (radiation-irritated skin) seriously affects the quality of life of breast cancer patients after treatment. This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect. Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical examinations, questionnaire surveys, skin observation and measurements, and photographs. The total study time is at least 3 months. The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate. The skin physiological parameters will be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer. Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4
Verify or expand the search:
- PubMed search for NCT06040983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06040983 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China Medical University Hospital
- Last refreshed: 18 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06040983.
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