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

Primary Purpose

Hyperpigmentation, Post-inflammatory Hyperpigmentation, Acne

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical Cetyl Tranexamate Mesylate
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperpigmentation

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Topical Cetyl Tranexamate Mesylate

    Arm Description

    Product will be used on the face twice daily in the morning and in the evening for 2 weeks.

    Outcomes

    Primary Outcome Measures

    Facial skin pigment intensity of 3 pre-identified lesions
    Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions

    Secondary Outcome Measures

    Facial skin pigment intensity of 3 pre-identified lesions
    Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
    Self-perception of skin pigmentation
    Survey-based self-assessment of facial skin pigmentation
    Self-perception of skin pigmentation
    Survey-based self-assessment of facial skin pigmentation
    Self-perception of skin redness
    Survey-based self-assessment of aspects of skin redness
    Self-perception of skin redness
    Survey-based self-assessment of aspects of skin redness

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Integrative Skin Science and Research
    Collaborators
    Actera
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080035
    Brief Title
    The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
    Official Title
    Open-label, Prospective Study on the Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Integrative Skin Science and Research
    Collaborators
    Actera

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 hypothedized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperpigmentation, Post-inflammatory Hyperpigmentation, Acne

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical Cetyl Tranexamate Mesylate
    Arm Type
    Experimental
    Arm Description
    Product will be used on the face twice daily in the morning and in the evening for 2 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Topical Cetyl Tranexamate Mesylate
    Intervention Description
    Topical product will be applied onto clean skin morning and night.
    Primary Outcome Measure Information:
    Title
    Facial skin pigment intensity of 3 pre-identified lesions
    Description
    Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Facial skin pigment intensity of 3 pre-identified lesions
    Description
    Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
    Time Frame
    1 week
    Title
    Self-perception of skin pigmentation
    Description
    Survey-based self-assessment of facial skin pigmentation
    Time Frame
    1 week
    Title
    Self-perception of skin pigmentation
    Description
    Survey-based self-assessment of facial skin pigmentation
    Time Frame
    2 week
    Title
    Self-perception of skin redness
    Description
    Survey-based self-assessment of aspects of skin redness
    Time Frame
    1 week
    Title
    Self-perception of skin redness
    Description
    Survey-based self-assessment of aspects of skin redness
    Time Frame
    2 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nhi P Nguyen, BS
    Phone
    9167502463
    Email
    nhi@integrativeskinresearch.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raja Sivamani, MD MS AP
    Organizational Affiliation
    Integrative Skin Science and Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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