Retinoic acid
Drugtopical administration in melasma lesions
Other names: Niacinamide, Sunscreen
NCT Number: NCT03392623
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
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Notify Me18 year–50 year
Female
Interventional
Early Phase 1
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
topical administration in melasma lesions
Other names: Niacinamide, Sunscreen
Measurement of erythema and luminosity through a colorimeter
topical administration in melasma lesions
topical administration in melasma lesions
Time frame: 8 weeks
Decrease in levels of expression of DNA methyl transferases
Time frame: 8 weeks
decrease in the MASI score
Universidad Autonoma de San Luis Potosí
Other
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