Clinical trial NCT06475482: Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
Official title: Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheilitis
Keywords: Cheilitis
Aging
Lip roughness
Prevention
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective evaluation
timeFrame: 30 minutes per 1 participant
Secondary outcomes:
measure: Subjective evaluation
timeFrame: 5 minutes per 1 participant
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of dentistry, Chulalongkorn university
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.