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

• 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.

Study Overview

• Status: Completed
• Conditions: Cheilitis
• Intervention / Treatment: Other: Petroleum gel; Other: Lip hydrant

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Faculty of Dentistry, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Petroleum gel (Vaseline); control group	Other: Petroleum gel; Vaseline
Active Comparator: Lip hydrant; experimental group	Other: Lip hydrant; lip hydrant containing peppermint oil, perilla frutescens, and Emblica fruit extract or petroleum gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective evaluation	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	30 minutes per 1 participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evaluation	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	5 minutes per 1 participant

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Publications and helpful links

General Publications

• Tamura E, Ishikawa J, Yasuda Y, Yamamoto T. The efficacy of synthetic pseudo-ceramide for dry and rough lips. Int J Cosmet Sci. 2021 Apr;43(2):158-164. doi: 10.1111/ics.12677. Epub 2021 Mar 31.
• Tamura E, Yasumori H, Yamamoto T. The efficacy of a highly occlusive formulation for dry lips. Int J Cosmet Sci. 2020 Feb;42(1):46-52. doi: 10.1111/ics.12583.
• Trookman NS, Rizer RL, Ford R, Mehta R, Gotz V. Clinical assessment of a combination lip treatment to restore moisturization and fullness. J Clin Aesthet Dermatol. 2009 Dec;2(12):44-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Aging; Cheilitis; Lip roughness
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Cheilitis
• Other Study ID Numbers: HREC-DCU2023-060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No