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

NCT03392623 | Completed Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 71-15
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Melasma

Keywords

Epigenetics, Malar melasma,

Outcome Measures

Primary Outcomes (1)

• improve in the level of DNA methylated

  Decrease in levels of expression of DNA methyl transferases

  8 weeks

Secondary Outcomes (1)

• improve in the clinical severity of melasma

  8 weeks

Study Arms (4)

Control group

OTHER

Macules of melasma without any treatment

Device: colorimetry measurement

Niacinamide group

EXPERIMENTAL

Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks

Device: colorimetry measurement; Drug: Niacinamide

Retinoic acid group

EXPERIMENTAL

Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks

Drug: Retinoic acid; Device: colorimetry measurement

Sunscreen group

PLACEBO COMPARATOR

Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks

Device: colorimetry measurement; Drug: sunscreen

Interventions

Retinoic acid DRUG

topical administration in melasma lesions

Also known as: Niacinamide, Sunscreen

Retinoic acid group

colorimetry measurement DEVICE

Measurement of erythema and luminosity through a colorimeter

Control group; Niacinamide group; Retinoic acid group; Sunscreen group

sunscreen DRUG

topical administration in melasma lesions

Sunscreen group

Niacinamide DRUG

topical administration in melasma lesions

Niacinamide group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

MeSH Terms

Conditions

Melanosis

Interventions

Tretinoin; Niacinamide; Sunscreening Agents

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double bind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 8, 2018
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share