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A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

Primary Purpose

Solar Lentigines

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tri-luma
Cryotherapy (CRY-AC3® device)
Sponsored by
Brazilan Center for Studies in Dermatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Solar Lentigines focused on measuring Lentigines, Cryotherapy, hyperpigmentation

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
  • Female and male subjects;
  • Phototype II to IV;
  • Subjects aged between 40 and 65 years;
  • Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter
  • History of post-inflammatory hyperpigmentation on body or face
  • Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
  • Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
  • Availability of the subject throughout the study;
  • Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
  • Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.

Exclusion Criteria:

  • Pregnant women or women intending to become pregnant in the following 5 months after screening;
  • Lactation period;
  • Subjects participating in other clinical trials;
  • Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
  • Subjects with neoplastic, muscular or neurological diseases;
  • Subjects with inflammation or active infection in the area to be studied;
  • Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula,
  • Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
  • Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (From Week 2 up to Week 13) Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.

    Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13) Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.

    Outcomes

    Primary Outcome Measures

    Solar Lentigines Count
    Solar lentigines count up to 13 weeks

    Secondary Outcome Measures

    Change From Baseline in Melanin Levels
    This assessment was made using a narrowband reflectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments. The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin.

    Full Information

    First Posted
    January 4, 2013
    Last Updated
    September 23, 2020
    Sponsor
    Brazilan Center for Studies in Dermatology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01778179
    Brief Title
    A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
    Official Title
    Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brazilan Center for Studies in Dermatology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
    Detailed Description
    To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Solar Lentigines
    Keywords
    Lentigines, Cryotherapy, hyperpigmentation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (From Week 2 up to Week 13) Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.
    Arm Title
    Group 2
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13) Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.
    Intervention Type
    Drug
    Intervention Name(s)
    Tri-luma
    Intervention Description
    Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks. Post-procedure phase (From week 2 up to Week 13 - Visit ) - Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cryotherapy (CRY-AC3® device)
    Intervention Description
    Procedure performed at week 2.
    Primary Outcome Measure Information:
    Title
    Solar Lentigines Count
    Description
    Solar lentigines count up to 13 weeks
    Time Frame
    up to 13 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Melanin Levels
    Description
    This assessment was made using a narrowband reflectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments. The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin.
    Time Frame
    Baseline and up to 13 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol; Female and male subjects; Phototype II to IV; Subjects aged between 40 and 65 years; Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter History of post-inflammatory hyperpigmentation on body or face Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation; Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study; Availability of the subject throughout the study; Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study; Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol. Exclusion Criteria: Pregnant women or women intending to become pregnant in the following 5 months after screening; Lactation period; Subjects participating in other clinical trials; Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results; Subjects with neoplastic, muscular or neurological diseases; Subjects with inflammation or active infection in the area to be studied; Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol; Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Doris Hexsel, MD
    Organizational Affiliation
    Brazilian Center for Studies in Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

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