Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-03

Study Completion Date

2024-03-27

Brief Summary

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* The goal of this clinical trial is to evaluate the efficacy of the novel polyherbal lip hydrant on dryness, fine lines and color of the lips in 66Thai people aged between 18-40 years old. The inclusion criteria will include subjects with subjective complaint of dry lips.The main question it aims to answer is Does the novel polyherbal lip hydrant improve biophysical barrier of the lips?
* Participant will be asked to apply the lip hydrant or the petroleum gel once a day before bedtime, and refrain from using other lip products throughout the clinical trial period (28 days).
* Researchers will compare control group (Petroleum gel) with lip hydrant group to see whether biophysical barrier (wrinkles, colors, fine lines, roughness) improve or not.

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Detailed Description

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Conditions

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Cheilitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized, double-blind, controlled trial will be conducted at the Faculty of Dentistry, Chulalongkorn University. The 66 participants will be randomly assigned to receive either lip hydrant containing peppermint oil, perilla frutescens, and Emblica fruit extract or petroleum gel. Both lip products will be given to allocated participants in the product container of identical appearance. Both subjects and investigators will be blinded to the study randomization.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Petroleum gel (Vaseline)

control group

Group Type PLACEBO_COMPARATOR

Petroleum gel

Intervention Type OTHER

Vaseline

Lip hydrant

experimental group

Group Type ACTIVE_COMPARATOR

Lip hydrant

Intervention Type OTHER

lip hydrant containing peppermint oil, perilla frutescens, and Emblica fruit extract or petroleum gel.

Interventions

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Lip hydrant

lip hydrant containing peppermint oil, perilla frutescens, and Emblica fruit extract or petroleum gel.

Intervention Type OTHER

Petroleum gel

Vaseline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* subjects with subjective complaint of dry lips;
* agree to comply with the study protocol
* agree not to apply any other products such as lipstick, lip gloss, lip conditioner to the lips other than the test product for the duration of the study
* provide a written informed consent prior to study enrollment.

Exclusion Criteria

* Participants those having visible skin conditions which might interfere with the outcome assessment
* having a history of sensitivities to cosmetics products, or moisturizers; - having a known or suspected intolerance or hypersensitivity to herbal products or any of its ingredient
* taking medication or under the care of a doctor for one month prior to the commencement of the study, and throughout the entire test period
* having other types of cheilitis except cheilitis simplex.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes