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

Sponsor

Universidad Autonoma de San Luis Potosí (Other)

Overall Status

Completed

CT.gov ID

NCT03392623

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Retinoic acid Device: colorimetry measurement Drug: sunscreen Drug: Niacinamide	Early Phase 1

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double bind

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Control group Macules of melasma without any treatment	Device: colorimetry measurement Measurement of erythema and luminosity through a colorimeter
Experimental: Niacinamide group Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks	Device: colorimetry measurement Measurement of erythema and luminosity through a colorimeter Drug: Niacinamide topical administration in melasma lesions
Experimental: Retinoic acid group Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks	Drug: Retinoic acid topical administration in melasma lesions Other Names: Niacinamide Sunscreen Device: colorimetry measurement Measurement of erythema and luminosity through a colorimeter
Placebo Comparator: Sunscreen group Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks	Device: colorimetry measurement Measurement of erythema and luminosity through a colorimeter Drug: sunscreen topical administration in melasma lesions

Outcome Measures

Primary Outcome Measures

improve in the level of DNA methylated [8 weeks]
Decrease in levels of expression of DNA methyl transferases

Secondary Outcome Measures

improve in the clinical severity of melasma [8 weeks]
decrease in the MASI score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.