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

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ClinicalTrials.gov Identifier: NCT03392623
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí

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 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2015
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. improve in the level of DNA methylated [ Time Frame: 8 weeks ]
    Decrease in levels of expression of DNA methyl transferases


Secondary Outcome Measures :
  1. improve in the clinical severity of melasma [ Time Frame: 8 weeks ]
    decrease in the MASI score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.


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Responsible Party: Juan Pablo Castanedo-Cazares, Medical Doctor, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT03392623    
Other Study ID Numbers: 71-15
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí:
Epigenetics, Malar melasma,
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Niacinamide
Niacin
Nicotinic Acids
Tretinoin
Sunscreening Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents