Opsin Receptors in Melasma

June 1, 2020 updated by: Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78290
        • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Retinoic Acid
patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter
Drug: Retinoic acid
To evaluate the role of Opsin receptors in melasma. The patients were treated with 0.05% Retinoic Acid, a regular therapy to treatment melasma, a ligand of Opsin receptors. Also, Uv-Visible light filter treatment as a posible opsin receptor blocker
PLACEBO_COMPARATOR: Sunscreen
patients with melasma treated with UV-Visible light filter alone
Drug: Retinoic acid
To evaluate the role of Opsin receptors in melasma. The patients were treated with 0.05% Retinoic Acid, a regular therapy to treatment melasma, a ligand of Opsin receptors. Also, Uv-Visible light filter treatment as a posible opsin receptor blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MASI score
Time Frame: 3 months
Melasma Activity and Severity Index
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opsin receptors
Time Frame: 3 months
Relative Expression of the opsin receptors by RT-qPCR
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Collaborators

Hospital Central "Dr. Ignacio Morones Prieto"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

December 15, 2019

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPN3Mel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melasma

Clinical Trials on Retinoic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe