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DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.

Primary Purpose

Melasma

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Retinoic acid
colorimetry measurement
sunscreen
Niacinamide
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Melasma focused on measuring Epigenetics, Malar melasma,

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.

Exclusion Criteria:

Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver).

Have received treatment in the last 2 months. Regular use of sunscreen.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Control group

    Niacinamide group

    Retinoic acid group

    Sunscreen group

    Arm Description

    Macules of melasma without any treatment

    Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks

    Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks

    Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks

    Outcomes

    Primary Outcome Measures

    improve in the level of DNA methylated
    Decrease in levels of expression of DNA methyl transferases

    Secondary Outcome Measures

    improve in the clinical severity of melasma
    decrease in the MASI score

    Full Information

    First Posted
    January 2, 2018
    Last Updated
    January 6, 2018
    Sponsor
    Universidad Autonoma de San Luis Potosí
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03392623
    Brief Title
    DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
    Official Title
    DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2016 (Actual)
    Study Completion Date
    December 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de San Luis Potosí

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
    Detailed Description
    OBJECTIVE: Recognize the DNA methylation status of the malar melasma and perilesional skin, and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025% retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real time-PCR (polymerase chain reaction amplification), immunohistochemistry and immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated compared with unaffected skin in all subjects indicating hypermethylation of DNA. Hypermethylation decreased by S (7 vs 3 times relative expression, p<0.05), RA (7 vs 2 times relative expression p<0.05), and N (7 vs 1 relative expression p<0.01) correlated with clinical improvement, this was also supported by immunohistochemistry and immunofluorescence. CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions. Environmental factors such as sun radiation may induce DNA hypermethylation triggering hyperpigmentation trough the activation of pathways regulated by epigenetic modifications. Thus, decreasing methylation by sunscreen protection and the genetic transcription modification through N and RA, may allow their clinical improvement regardless its depigmenting effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma
    Keywords
    Epigenetics, Malar melasma,

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    double bind
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Macules of melasma without any treatment
    Arm Title
    Niacinamide group
    Arm Type
    Experimental
    Arm Description
    Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks
    Arm Title
    Retinoic acid group
    Arm Type
    Experimental
    Arm Description
    Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks
    Arm Title
    Sunscreen group
    Arm Type
    Placebo Comparator
    Arm Description
    Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Retinoic acid
    Other Intervention Name(s)
    Niacinamide, Sunscreen
    Intervention Description
    topical administration in melasma lesions
    Intervention Type
    Device
    Intervention Name(s)
    colorimetry measurement
    Intervention Description
    Measurement of erythema and luminosity through a colorimeter
    Intervention Type
    Drug
    Intervention Name(s)
    sunscreen
    Intervention Description
    topical administration in melasma lesions
    Intervention Type
    Drug
    Intervention Name(s)
    Niacinamide
    Intervention Description
    topical administration in melasma lesions
    Primary Outcome Measure Information:
    Title
    improve in the level of DNA methylated
    Description
    Decrease in levels of expression of DNA methyl transferases
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    improve in the clinical severity of melasma
    Description
    decrease in the MASI score
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study. Exclusion Criteria: Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver). Have received treatment in the last 2 months. Regular use of sunscreen.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.

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