Impact of Topical Clobetasol on Gingival Crevicular Fluid... | NCT05818618

Studies
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus

NCT05818618

Sponsor

University of Catania

Status

Completed

Last Update Posted

Aug 25, 2023Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Oral Lichen Planus

Interventions

Clobetasol Topical Gel
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2020Actual

Primary Completion Date

Jul 5, 2023Actual

Completion Date

Aug 10, 2023Actual

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2023

Last Update Posted Date

Aug 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).

Detailed Description

A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables.

At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clobetasol propionate 0,05% gel	Active Comparator	Patients were treated with a topic gel of clobetasol propionate 0,05%	Drug: Clobetasol Topical Gel
Placebo	Placebo Comparator	Patients were treated with a topic placebo gel control	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clobetasol Topical Gel	Drug	Topic Clobetasol gel applied locally on OLP lesions.	Clobetasol propionate 0,05% gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
miRNAs GCF levels	The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
OLP disease severity scores	The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4)	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis.

Exclusion Criteria:

1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gaetano Isola	University of Catania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico G. Rodolico		Catania		95124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol

Types

Not provided

Time Frame

5 months

Access Criteria

Pubmed

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

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Browse Branches

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