Acute Radiation DermatitisNCT05079763
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
A study testing Bacterial cellulose-monolaurin hydrogel in people with Acute Radiation Dermatitis, run by University of the Philippines at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Acute Radiation Dermatitis
- What is being tested?
- Bacterial cellulose-monolaurin hydrogel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Sep 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex at birth
- Age at least 18 years at the time of invitation
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
- With histopathologic diagnosis of breast carcinoma
- Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
- Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy
Who cannot join
- Pregnant or lactating
- With concurrent or previous history of any malignancy
- With history of mediastinal or thoracic irradiation
- With current bilateral synchronous breast carcinoma
- With diagnosis of metastases from any form of breast cancer
- With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
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- With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
- With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
- Inability to personally provide informed consent or to personally comply with skin care instructions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claudine Yap-Silva, MD contact
Philippines1 site, 1 recruiting
- Recruiting
Philippine General Hospital
Manila, 1000
Claudine Yap-Silva, MD, cysilva@up.edu.ph
About this study
Official title: Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
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
- Being tested
- Bacterial cellulose-monolaurin hydrogel, Placebo cream
- Keywords
- ARD, postmastectomy, breast cancer, breast adenocarcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial cellulose-monolaurin hydrogelOther
Hydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
Placebo creamOther
Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Application of bacterial cellulose-monolaurin hydrogel in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan Receives: Other: Bacterial cellulose-monolaurin hydrogel |
| Placebo Arm | Placebo comparator | Application of placebo cream in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of high grade acute radiation dermatitis
High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3
Measured: Baseline to Week 4 post-radiotherapy
Secondary outcomes (2)
Distribution of participants in terms of ARD CTCAE grades
Distribution of participants across the ARD CTCAE grades (0-5) in the two interventions will be compared
Measured: Baseline to Week 4 post-radiotherapy
Patient-reported quality of life
Outcome will be assessed using the Skindex-16 (SD-16) questionnaire, administered on a weekly basis from baseline up to two weeks post-radiotherapy
Measured: Baseline to Week 4 post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bacterial cellulose-monolaurin hydrogel
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079763
- Sponsor's protocol ID
- UPMREB 2021-140-01
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05079763
- Acronym / sponsor ID
- UPMREB 2021-140-01
- Conditions
- Acute Radiation Dermatitis
- Keywords
- ARD, postmastectomy, breast cancer, breast adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Bacterial cellulose-monolaurin hydrogel
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Bacterial cellulose-monolaurin hydrogelApplication of bacterial cellulose-monolaurin hydrogel in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan |
| Placebo Arm | Placebo comparator | Other: Placebo creamApplication of placebo cream in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female sex at birth
- Age at least 18 years at the time of invitation
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
- With histopathologic diagnosis of breast carcinoma
- Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
Key exclusion criteria (9 listed)
- Pregnant or lactating
- With concurrent or previous history of any malignancy
- With history of mediastinal or thoracic irradiation
- With current bilateral synchronous breast carcinoma
- With diagnosis of metastases from any form of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial cellulose-monolaurin hydrogelHydrogel containing Komagataeibacter xylinus-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water | Other | Experimental arm |
| Placebo creamCream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben | Other | Placebo Arm |
Primary outcome
Incidence of high grade acute radiation dermatitis
Time frame: Baseline to Week 4 post-radiotherapy
High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3
2 secondary outcomes
Distribution of participants in terms of ARD CTCAE grades
Time frame: Baseline to Week 4 post-radiotherapy
Patient-reported quality of life
Time frame: Baseline to Week 4 post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudine Yap-Silva, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacterial cellulose-monolaurin hydrogel in people with Acute Radiation Dermatitis, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aedrian A Abrilla, MD (+639363193980, aaabrilla@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of high grade acute radiation dermatitis (time frame: Baseline to Week 4 post-radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.