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OpenTrials
Completed

NCT Number: NCT06475482

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.

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Key information

Conditions

Cheilitis Lip Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Chulalongkorn university

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lip hydrant

Other

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

Petroleum gel

Other

Vaseline

Primary outcomes

  1. Objective evaluation

    Time frame: 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 outcomes

  1. Subjective evaluation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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