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

Universidad Autonoma de San Luis Potosí

Status and phase: Completed; Early Phase 1

Conditions: Melasma

Treatments: Device: colorimetry measurement; Drug: Retinoic acid; Drug: sunscreen; Drug: Niacinamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03392623

71-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 4 patient groups, including a placebo group

Control group

Other group

Description:

Macules of melasma without any treatment

Treatment:

Device: colorimetry measurement

Niacinamide group

Experimental group

Description:

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

Treatment:

Drug: Niacinamide

Device: colorimetry measurement

Retinoic acid group

Experimental group

Description:

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

Treatment:

Drug: Retinoic acid

Device: colorimetry measurement

Sunscreen group

Placebo Comparator group

Description:

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

Treatment:

Drug: sunscreen

Device: colorimetry measurement