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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-12-01

Brief Summary

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BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.

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Detailed Description

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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.

Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

double bind

Study Groups

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Control group

Macules of melasma without any treatment

Group Type OTHER

colorimetry measurement

Intervention Type DEVICE

Measurement of erythema and luminosity through a colorimeter

Niacinamide group

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

Group Type EXPERIMENTAL

colorimetry measurement

Intervention Type DEVICE

Measurement of erythema and luminosity through a colorimeter

Niacinamide

Intervention Type DRUG

topical administration in melasma lesions

Retinoic acid group

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

Group Type EXPERIMENTAL

Retinoic acid

Intervention Type DRUG

topical administration in melasma lesions

colorimetry measurement

Intervention Type DEVICE

Measurement of erythema and luminosity through a colorimeter

Sunscreen group

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

Group Type PLACEBO_COMPARATOR

colorimetry measurement

Intervention Type DEVICE

Measurement of erythema and luminosity through a colorimeter

sunscreen

Intervention Type DRUG

topical administration in melasma lesions

Interventions

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Retinoic acid

topical administration in melasma lesions

Intervention Type DRUG

colorimetry measurement

Measurement of erythema and luminosity through a colorimeter

Intervention Type DEVICE

sunscreen

topical administration in melasma lesions

Intervention Type DRUG

Niacinamide

topical administration in melasma lesions

Intervention Type DRUG

Other Intervention Names

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Niacinamide Sunscreen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes