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

Not Applicable

Completed

• Conditions: Cheilitis

• Registration Number: NCT06475482
• Lead Sponsor: Chulalongkorn University

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-03
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Primary Completion: 2024-03-27
• Study Completion: 2024-03-27
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective evaluation	30 minutes per 1 participant	Objective evaluation; using; * Fotofinder to take a photograph of the lips.; * Modified visual assessment scale to assess lip roughness score divided to 4 levels (1=not dry 2= dry without desquamated 3 = dry with slightly desquamated 4 = dry with heavy desquamated) and lip wrinkle score divided into 3 levels (1 = Almost no vertical wrinkle 2 = No deep vertical wrinkle 3= Many deep vertical wrinkle); * Antera 3D. (Texture, wrinkle, melanin pigment and hemoglobin) the value from Antera appear as the number with no unit,; * Digital camera to evaluate overall clinical improvement of the lips

Secondary Outcome Measures

Name	Time	Method
Subjective evaluation	5 minutes per 1 participant	will be assessed at day 0 (baseline), day 1 and day 28 by using a self-reported questionnaire in scale from 1-10 points for patient's dry lip score which higher score means more dry lip feeling

Trial Locations

Locations (1)

Faculty of dentistry, Chulalongkorn university; 🇹🇭 Bangkok, Thailand