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

C

Chulalongkorn University

Status

Completed

Conditions

Cheilitis

Treatments

Other: Petroleum gel
Other: Lip hydrant

Study type

Interventional

Funder types

Other

Identifiers

NCT06475482
HREC-DCU2023-060

Details and patient eligibility

About

  • 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.

Enrollment

66 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups, including a placebo group

Petroleum gel (Vaseline)
Placebo Comparator group
Description:
control group
Treatment:
Other: Petroleum gel
Lip hydrant
Active Comparator group
Description:
experimental group
Treatment:
Other: Lip hydrant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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