DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 28
- Primary Endpoint
- improve in the level of DNA methylated
Study Overview
Brief Summary
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Masking Description
double bind
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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.
Arms & Interventions
Control group
Macules of melasma without any treatment
Intervention: colorimetry measurement (Device)
Niacinamide group
Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks
Intervention: colorimetry measurement (Device)
Niacinamide group
Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks
Intervention: Niacinamide (Drug)
Retinoic acid group
Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks
Intervention: Retinoic acid (Drug)
Retinoic acid group
Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks
Intervention: colorimetry measurement (Device)
Sunscreen group
Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks
Intervention: colorimetry measurement (Device)
Sunscreen group
Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks
Intervention: sunscreen (Drug)
Outcomes
Primary Outcomes
improve in the level of DNA methylated
Time Frame: 8 weeks
Decrease in levels of expression of DNA methyl transferases
Secondary Outcomes
- improve in the clinical severity of melasma(8 weeks)
Investigators
Juan Pablo Castanedo-Cazares
Medical Doctor
Universidad Autonoma de San Luis Potosí