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Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

NCT05079763 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Acute Radiation Dermatitis

Interventions

OTHER

Bacterial cellulose-monolaurin hydrogel

Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water

OTHER

Placebo cream

Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben

Sponsors & Collaborators

  • University of the Philippines

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05079763 on ClinicalTrials.gov