An Early Phase 1 interventional study of Retinoic acid and colorimetry measurement in Melasma, sponsored by Universidad Autonoma de San Luis Potosí. Completed. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Universidad Autonoma de San Luis Potosí · Early Phase 1, Interventional, and Other
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
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.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Universidad Autonoma de San Luis Potosí is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
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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.
Macules of melasma without any treatment
Device: colorimetry measurement
Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks
Device: colorimetry measurement · Drug: Niacinamide
Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks
Drug: Retinoic acid · Device: colorimetry measurement
Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks
Device: colorimetry measurement · Drug: sunscreen
topical administration in melasma lesions
Also known as: Niacinamide, Sunscreen
Measurement of erythema and luminosity through a colorimeter
topical administration in melasma lesions
topical administration in melasma lesions
improve in the level of DNA methylated
Decrease in levels of expression of DNA methyl transferases
Time frame: 8 weeks
improve in the clinical severity of melasma
decrease in the MASI score
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Jan 2016, 12 months.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tretinoin · Niacinamide
Universidad Autonoma de San Luis Potosí