NCT04417348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

June 1, 2020

Last Update Submit

June 1, 2020

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

  • MASI score

    Melasma Activity and Severity Index

    3 months

Secondary Outcomes (1)

  • Opsin receptors

    3 months

Study Arms (2)

Retinoic Acid

ACTIVE COMPARATOR

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

Drug: Retinoic acid

Sunscreen

PLACEBO COMPARATOR

patients with melasma treated with UV-Visible light filter alone

Drug: Retinoic acid

Interventions

Retinoic acidDRUG

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

Retinoic AcidSunscreen

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78290, Mexico

Location

Related Publications (2)

  • Regazzetti C, Sormani L, Debayle D, Bernerd F, Tulic MK, De Donatis GM, Chignon-Sicard B, Rocchi S, Passeron T. Melanocytes Sense Blue Light and Regulate Pigmentation through Opsin-3. J Invest Dermatol. 2018 Jan;138(1):171-178. doi: 10.1016/j.jid.2017.07.833. Epub 2017 Aug 24.

    PMID: 28842328RESULT

  • Ozdeslik RN, Olinski LE, Trieu MM, Oprian DD, Oancea E. Human nonvisual opsin 3 regulates pigmentation of epidermal melanocytes through functional interaction with melanocortin 1 receptor. Proc Natl Acad Sci U S A. 2019 Jun 4;116(23):11508-11517. doi: 10.1073/pnas.1902825116. Epub 2019 May 16.

    PMID: 31097585RESULT

MeSH Terms

Conditions

Melanosis

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunt professor

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

January 31, 2019

Primary Completion

September 30, 2019

Study Completion

December 15, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)