NCT05079763

Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Recruiting now NA Last updated 12 January 2026

What this trial tests

NA trial testing Bacterial cellulose-monolaurin hydrogel in Acute Radiation Dermatitis in 54 participants. Currently enrolling.

Timeline

1 September 2021

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	University of the Philippines
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	54
Start date	1 September 2021
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Philippines

Drugs / interventions tested

• Bacterial cellulose-monolaurin hydrogel
• Placebo cream

Conditions studied

• Acute Radiation Dermatitis — all drugs for Acute Radiation Dermatitis →

Sponsor

University of the Philippines

Who can join

Adults 18 to 80, female only, with Acute Radiation Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potentially leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bacterial immunotherapy: is it a weapon in our arsenal in the fight against cancer?
   Sharma S, Sharma H, Gogoi H. · · 2023 · cited 8× · PMID 38090593 · DOI 10.3389/fimmu.2023.1277677
2. A Comprehensive Review of Clinical Studies on Bacterial Cellulose: From the Earliest Uses to Contemporary Innovations.
   Meslier T, D'Antin JC, Julio G, Roig A. · · 2025 · cited 3× · PMID 40685851 · DOI 10.1002/adhm.202502189
3. Microorganisms and Breast Cancer: An In-Depth Analysis of Clinical Studies.
   Naderi N, Mosahebi A, Williams NR. · · 2023 · cited 2× · PMID 38276152 · DOI 10.3390/pathogens13010006
4. Mechanism-Inspired Biomaterials and Regenerative Therapies for Radiation-Induced Skin Injury.
   Zhou Y, Zhang X, Shen X, Xing S, et al · · 2026 · PMID 41858581 · DOI 10.2147/ijn.s568923
5. Recent advances in application of hydrogel-based nanomaterials in breast cancer: from drug delivery, immunotherapy mechanisms to clinical applications.
   Xu Y, Pan D, Yang Q, Huang C, et al · · 2026 · PMID 41857574 · DOI 10.1186/s12951-026-04238-z
6. 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