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NCT03988556: SafePBM
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
NA trial testing Photobiomodulation using CareMin650 at 6 Joules (curative intent) in Oral Mucositis Due to Radiation in 72 participants. Completed in 17 December 2020.
17 December 2020
Quick facts
| Lead sponsor | NeoMedLight |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 72 |
| Start date | 4 July 2019 |
| Primary completion | 17 December 2020 |
| Estimated completion | 17 December 2020 |
| Sites | 5 locations across France |
Drugs / interventions tested
- Photobiomodulation using CareMin650 at 6 Joules (curative intent)
- Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
Conditions studied
- Oral Mucositis Due to Radiation — all drugs for Oral Mucositis Due to Radiation →
- Radiation Dermatitis — all drugs for Radiation Dermatitis →
Sponsor
NeoMedLight
Who can join
18 and older, any sex, with Oral Mucositis Due to Radiation or Radiation Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oral Mucositis: An Update on Innate Immunity and New Interventional Targets.
Chen C, Zhang Q, Yu W, Chang B, et al · · 2020 · cited 44× · PMID 32479139 · DOI 10.1177/0022034520925421 -
New photobiomodulation device for prevention and cure of radiotherapy-induced oral mucositis and dermatitis: results of the prospective Safe PBM study.
Bensadoun RJ, Bollet MA, Liem X, Cao K, et al · · 2022 · cited 11× · PMID 34537889 · DOI 10.1007/s00520-021-06574-2
Verify or expand the search:
- PubMed search for NCT03988556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other NeoMedLight trials
Trials by the same sponsor.
- NCT04699487 — Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy · NA · completed
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 NCT03988556 (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 NeoMedLight
- Last refreshed: 30 April 2021
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/NCT03988556.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing