CheilitisNCT06475482
Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
A study testing Lip hydrant and Petroleum gel in people with Cheilitis, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cheilitis
- What is being tested?
- Lip hydrant and Petroleum gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- 3 Jan 2024to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
- 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.
- Conditions
- Cheilitis
- Being tested
- Lip hydrant, Petroleum gel
- Keywords
- Cheilitis, Aging, Lip roughness, Prevention
- Medical subject headings
- Cheilitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lip hydrantOther
lip hydrant containing peppermint oil, perilla frutescens, and Emblica fruit extract or petroleum gel.
Petroleum gelOther
Vaseline
| Study group | Role | What they receive |
|---|---|---|
| Petroleum gel (Vaseline) | Placebo comparator | control group Receives: Other: Petroleum gel |
| Lip hydrant | Active comparator | experimental group Receives: Other: Lip hydrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes per 1 participant
Secondary outcomes (1)
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
Measured: 5 minutes per 1 participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start3 Jan 2024
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CheilitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475482
- Sponsor's protocol ID
- HREC-DCU2023-060
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33258166Tamura 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.
PubMed 31571236Trookman 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.
PubMed 20725584Sutthiboonyapan P, Sriratanasak N, Innets B, Angkanaporn N, Suntornchot P, Panyain W, Porntaveetus T, Wiriyakijja P, Chanvorachote P. A Randomized Double-Blind Controlled Evaluation of the Therapeutic Benefits of an Herbal Lip Hydrant. J Cosmet Dermatol. 2025 Mar;24(3):e70041. doi: 10.1111/jocd.70041.
PubMed 40013415
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
- ClinicalTrials.gov ID
- NCT06475482
- Acronym / sponsor ID
- HREC-DCU2023-060
- Conditions
- Cheilitis
- Keywords
- Cheilitis, Aging, Lip roughness, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Petroleum gel (Vaseline) | Placebo comparator | Other: Petroleum gelcontrol group |
| Lip hydrant | Active comparator | Other: Lip hydrantexperimental group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lip hydrantlip hydrant containing peppermint oil, perilla frutescens, and Emblica fruit extract or petroleum gel. | Other | Lip hydrant |
| Petroleum gelVaseline | Other | Petroleum gel (Vaseline) |
Primary outcome
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
1 secondary outcome
Subjective evaluation
Time frame: 5 minutes per 1 participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 33258166Tamura 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.
- Background: PubMed 31571236Tamura 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.
- Background: PubMed 20725584Trookman 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.
- Derived from this study: PubMed 40013415Sutthiboonyapan P, Sriratanasak N, Innets B, Angkanaporn N, Suntornchot P, Panyain W, Porntaveetus T, Wiriyakijja P, Chanvorachote P. A Randomized Double-Blind Controlled Evaluation of the Therapeutic Benefits of an Herbal Lip Hydrant. J Cosmet Dermatol. 2025 Mar;24(3):e70041. doi: 10.1111/jocd.70041.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lip hydrant and Petroleum gel in people with Cheilitis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective evaluation (time frame: 30 minutes per 1 participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06475482, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.