The Effects of Cetyl Tranexamate Mesylate on the Appearan... | NCT06080035

Studies
The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation

NCT06080035

Sponsor

Integrative Skin Science and Research

Status

Completed

Last Update Posted

Aug 28, 2024Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Hyperpigmentation
Post-inflammatory Hyperpigmentation
Acne

Interventions

Topical Cetyl Tranexamate Mesylate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2023Actual

Primary Completion Date

Jan 11, 2024Actual

Completion Date

Jan 11, 2024Actual

First Submitted Date

Oct 2, 2023

First Submission Date that Met QC Criteria

Oct 6, 2023

First Posted Date

Oct 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2024

Last Update Posted Date

Aug 28, 2024Actual

Name	Class
Actera	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topical Cetyl Tranexamate Mesylate	Experimental	Product will be used on the face twice daily in the morning and in the evening for 2 weeks.	Other: Topical Cetyl Tranexamate Mesylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical Cetyl Tranexamate Mesylate	Other	Topical product will be applied onto clean skin morning and night.	Topical Cetyl Tranexamate Mesylate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facial skin pigment intensity of 3 pre-identified lesions	Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Facial skin pigment intensity of 3 pre-identified lesions	Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions	1 week
Self-perception of skin pigmentation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raja Sivamani, MD MS AP	Integrative Skin Science and Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrative Skin and Research		Sacramento	California	95815	United States

Condition Browse Module

MeSH Terms

ID	Term
D017495	Hyperpigmentation
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017486	Acneiform Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided