This is a clinical study to assess the effectiveness and safety of the Drizlin moisturizing bio-patch for treating patients who have below average salivary flow.

An open-labelled, randomized, two-arm, non-inferior clinical investigation plan to evaluate the efficacy of novel moisturizing bio-patch compared to standard of care in Xerostomia (radiotherapy-induced xerostomia / Sjogren’s syndrome / drug-induced xerostomia) - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063722

Enrollment

112

Registered

2024-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K117- Disturbances of salivary secretion

Interventions

Intervention1: Drizlin Oral bio-patch [Class- A Medical device]: Drizlin oral patches are intraoral moisturizing patches that give continuous hydration of oral cavity to those who suffer from severe d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients whose salivary flow rate7 is less than 0.1 ml/min (subsets - Sjogren’s syndrome & drug-induced xerostomia); 2. Patients who fall under any one of the following categories: a. Post-radiotherapy patients (= 6 months) who underwent treatment for head & neck cancers. b. Who are diagnosed with Sjogren’s syndrome; c. Who are diagnosed with drug-induced xerostomia; 3. Patients who are willing to give voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are currently under chemotherapy; 2. Patients who are terminally ill and are having any other condition, in the opinion of the investigator, which would affect the safety of the patient; 3. Patients with known history of hypersensitivity to mucosal patches; 4. Female patients who are breast-feeding/ pregnant, or intends to become pregnant during the clinical investigation. 5. Patients who participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration.

Design outcomes

Primary

Measure	Time frame
1)Change in dryness of mouth score based on VAS scale. 2) Treatment discontinuation rates: Early discontinuation, discontinuation due to study device-related adverse events.Timepoint: Baseline to end of study.	—

Secondary

Measure	Time frame
1) Change in burning sensation of buccal cavity based on VAS scale 2) Change in the moistness of oral cavity based on VAS scale 3) Change in nocturnal urinary frequency per day (subsets –Sjogren’s syndrome & drug-induced xerostomia) 4) Change in speaking difficulty based on VAS scale 5) Number & percentage of patients with study device-related adverse events. 6) Feedback on ease in the removal of moisturizing bio-patch at the end of the clinical investigation. 7) Change in simplified oral hygiene index (OHI-S)9 on a score of 0 – 6Timepoint: Baseline to end of study.	—

Measure

Time frame

1) Change in burning sensation of buccal cavity based on VAS scale 2) Change in the moistness of oral cavity based on VAS scale 3) Change in nocturnal urinary frequency per day (subsets –Sjogren’s syndrome & drug-induced xerostomia) 4) Change in speaking difficulty based on VAS scale 5) Number & percentage of patients with study device-related adverse events. 6) Feedback on ease in the removal of moisturizing bio-patch at the end of the clinical investigation. 7) Change in simplified oral hygiene index (OHI-S)9 on a score of 0 – 6Timepoint: Baseline to end of study.

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Countries

India

Contacts

Public ContactDr Saramma Mathew Fenn

Vinayaka Missions Sankarachariyar Dental College

drsarammamathewfenn@vmsdc.edu.in8754569193

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026