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Clinical Trials/NCT04417348
NCT04417348CompletedNot Applicable

Expression of Opsins Receptors in Melasma and Its Modification With UV-Visible Light Sunscreen and 0.05% Retinoic Acid.

Universidad Autonoma de San Luis Potosí1 site in 1 country15 target enrollmentStarted: January 31, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
MASI score

Study Overview

Brief Summary

Melasma is a hyperpigmentation disorder that is probably exacerbated by visible light. Opsin receptors (OPN 1, 2, 3, 4 y 5) were described in the skin, being capable of activating melanogenesis induced by visible light. The aim of this study was to evaluate the expression of OPN in melasma skin and its changes following treatment with UV-Vis filter and 0.05% retinoic acid for 12 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients diagnosed with melasma, of 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had Melasma Activity and Severity Index (MASI) scores higher than 7

Exclusion Criteria

  • pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exercise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year

Arms & Interventions

Retinoic Acid

Active Comparator

patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter

Intervention: Retinoic acid (Drug)

Sunscreen

Placebo Comparator

patients with melasma treated with UV-Visible light filter alone

Intervention: Retinoic acid (Drug)

Outcomes

Primary Outcomes

MASI score

Time Frame: 3 months

Melasma Activity and Severity Index

Secondary Outcomes

  • Opsin receptors(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Juan Pablo Castanedo-Cazares

Adjunt professor

Universidad Autonoma de San Luis Potosí

Study Sites (1)

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