Back to resultsOpsin Receptors in Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Retinoic acid
Sponsored by
About this trial
This is an interventional basic science trial for Melasma
Eligibility Criteria
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
Sites / Locations
- Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Retinoic Acid
Sunscreen
Arm Description
patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter
patients with melasma treated with UV-Visible light filter alone
Outcomes
Primary Outcome Measures
MASI score
Melasma Activity and Severity Index
Secondary Outcome Measures
Opsin receptors
Relative Expression of the opsin receptors by RT-qPCR
Full Information
NCT ID
NCT04417348
First Posted
June 1, 2020
Last Updated
June 1, 2020
Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
1. Study Identification
Unique Protocol Identification Number
NCT04417348
Brief Title
Opsin Receptors in Melasma
Official Title
Expression of Opsins Receptors in Melasma and Its Modification With UV-Visible Light Sunscreen and 0.05% Retinoic Acid.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retinoic Acid
Arm Type
Active Comparator
Arm Description
patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter
Arm Title
Sunscreen
Arm Type
Placebo Comparator
Arm Description
patients with melasma treated with UV-Visible light filter alone
Intervention Type
Drug
Intervention Name(s)
Retinoic acid
Intervention Description
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
Primary Outcome Measure Information:
Title
MASI score
Description
Melasma Activity and Severity Index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Opsin receptors
Description
Relative Expression of the opsin receptors by RT-qPCR
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
City
San Luis Potosí
ZIP/Postal Code
78290
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28842328
Citation
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.
Results Reference
result
PubMed Identifier
31097585
Citation
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.
Results Reference
result
Learn more about this trial
Opsin Receptors in Melasma
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