HyperpigmentationNCT06080035
The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
A study testing Topical Cetyl Tranexamate Mesylate in people with Hyperpigmentation and Post-inflammatory Hyperpigmentation, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector. Read more about this study
- Who is it for?
- Ages 14 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Post-inflammatory Hyperpigmentation, Acne
- What is being tested?
- Topical Cetyl Tranexamate Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 11 Jan 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 14 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males and females between the ages of 14 years of age until 55 years of age
- Individuals experiencing 3 different areas minimum of facial post-inflammatory hyperpigmentation in those with acne
Who cannot join
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- Those who are unwilling to discontinue hydroquinone, vitamin A/C/E, azelaic acid, kojic acid, bakuchiol, licorice root, retinol, niacinamide, alpha arbutin, and oral or topical tranexamic acid for two weeks to meet the washout criteria prior to enrolling and for the duration of the study.
- Subjects with any of the following facial cosmetic treatments within the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, or any other medical treatment administered by a physician or skin care professional which is designed to improve skin pigmentation.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin and Research
Sacramento, California, 95815
About this study
Official title: Open-label, Prospective Study on the Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.
Read the detailed description
Hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types III to VI on the Fitzpatrick skin classification scale. Hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. One of the treatments that are used to treat hyperpigmentation is tranexamic acid (TXA) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. Since TXA is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. Similar to TXA esters, Cetyl Tranexamate Mesylate (CTM) is hypothesized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.
- Conditions
- Hyperpigmentation, Post-inflammatory Hyperpigmentation, Acne
- Being tested
- Topical Cetyl Tranexamate Mesylate
- Medical subject headings
- Hyperpigmentation, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Cetyl Tranexamate MesylateOther
Topical product will be applied onto clean skin morning and night.
| Study group | Role | What they receive |
|---|---|---|
| Topical Cetyl Tranexamate Mesylate | Experimental | Product will be used on the face twice daily in the morning and in the evening for 2 weeks. Receives: Other: Topical Cetyl Tranexamate Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial skin pigment intensity of 3 pre-identified lesions
Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
Measured: 2 weeks
Secondary outcomes (5)
Facial skin pigment intensity of 3 pre-identified lesions
Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
Measured: 1 week
Self-perception of skin pigmentation
Survey-based self-assessment of facial skin pigmentation
Measured: 1 week
Self-perception of skin pigmentation
Survey-based self-assessment of facial skin pigmentation
Measured: 2 week
Self-perception of skin redness
Survey-based self-assessment of aspects of skin redness
Measured: 1 week
Self-perception of skin redness
Survey-based self-assessment of aspects of skin redness
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start6 Nov 2023
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Actera
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD MS AP, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080035
- Sponsor's protocol ID
- i23-01_CTM
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Prospective Study on the Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
- ClinicalTrials.gov ID
- NCT06080035
- Acronym / sponsor ID
- i23-01_CTM
- Conditions
- Hyperpigmentation, Post-inflammatory Hyperpigmentation, Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Actera
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 12 Oct 2023 (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 purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.
Detailed description
Hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types III to VI on the Fitzpatrick skin classification scale. Hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. One of the treatments that are used to treat hyperpigmentation is tranexamic acid (TXA) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. Since TXA is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. Similar to TXA esters, Cetyl Tranexamate Mesylate (CTM) is hypothesized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical Cetyl Tranexamate Mesylate | Experimental | Other: Topical Cetyl Tranexamate MesylateProduct will be used on the face twice daily in the morning and in the evening for 2 weeks. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Males and females between the ages of 14 years of age until 55 years of age
- Individuals experiencing 3 different areas minimum of facial post-inflammatory hyperpigmentation in those with acne
Key exclusion criteria (7 listed)
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- Those who are unwilling to discontinue hydroquinone, vitamin A/C/E, azelaic acid, kojic acid, bakuchiol, licorice root, retinol, niacinamide, alpha arbutin, and oral or topical tranexamic acid for two weeks to meet the washout criteria prior to enrolling and for the duration of the study.
- Subjects with any of the following facial cosmetic treatments within the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, or any other medical treatment administered by a physician or skin care professional which is designed to improve skin pigmentation.
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 |
|---|---|---|
| Topical Cetyl Tranexamate MesylateTopical product will be applied onto clean skin morning and night. | Other | Topical Cetyl Tranexamate Mesylate |
Primary outcome
Facial skin pigment intensity of 3 pre-identified lesions
Time frame: 2 weeks
Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
5 secondary outcomes
Facial skin pigment intensity of 3 pre-identified lesions
Time frame: 1 week
Self-perception of skin pigmentation
Time frame: 1 week
Self-perception of skin pigmentation
Time frame: 2 week
Self-perception of skin redness
Time frame: 1 week
Self-perception of skin redness
Time frame: 2 week
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 28 Aug 2024.
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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.
Raja Sivamani, MD MS AP principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Cetyl Tranexamate Mesylate in people with Hyperpigmentation and Post-inflammatory Hyperpigmentation, run by Integrative Skin Science and Research at 1 site in United States.
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 2 inclusion and 7 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 28 Aug 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 United States. 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. 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?
Facial skin pigment intensity of 3 pre-identified lesions (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.