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NCT04636242
Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Phase 3 trial testing Skin Biopsy in C. Acnes in 120 participants. Status unknown.
31 August 2021
Quick facts
| Lead sponsor | Rothman Institute Orthopaedics |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 22 August 2019 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Skin Biopsy
- 5 Aminolevulinic Acid + Phototherapy — full drug profile →
Conditions studied
- C. Acnes — all drugs for C. Acnes →
- Phototherapy — all drugs for Phototherapy →
- Postoperative Infection — all drugs for Postoperative Infection →
- Arthroscopic Rotator Cuff Repair — all drugs for Arthroscopic Rotator Cuff Repair →
Sponsor
Rothman Institute Orthopaedics
Who can join
Adults 18 to 80, male only, with C. Acnes or Phototherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections. -Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04636242
- Europe PMC full search
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- ESMO Meeting Library
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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 NCT04636242 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rothman Institute Orthopaedics
- Last refreshed: 19 November 2020
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/NCT04636242.
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