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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392623
• Other study ID #: 71-15
• Status: Completed
• Phase: Early Phase 1
• First received: January 2, 2018
• Last updated: January 6, 2018
• Start date: January 1, 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: January 2018
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 1, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Retinoic acid
topical administration in melasma lesions

Device:
• colorimetry measurement
Measurement of erythema and luminosity through a colorimeter

Drug:
• sunscreen
topical administration in melasma lesions
• Niacinamide
topical administration in melasma lesions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improve in the level of DNA methylated	Decrease in levels of expression of DNA methyl transferases	8 weeks
Secondary	improve in the clinical severity of melasma	decrease in the MASI score	8 weeks