NCT06475482CompletedNot Applicable
Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
Chulalongkorn University2 sites in 1 country66 target enrollmentStarted: January 3, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chulalongkorn University
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Objective evaluation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
- Subjective evaluation(5 minutes per 1 participant)
Investigators
Study Sites (2)
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