MelasmaNCT04417348
Opsin Receptors in Melasma
A study testing Retinoic acid in people with Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Retinoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 31 Jan 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78290
About this study
Official title: 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.
- Conditions
- Melasma
- Being tested
- Retinoic acid
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Retinoic Acid | Active comparator | patients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter Receives: Drug: Retinoic acid |
| Sunscreen | Placebo comparator | patients with melasma treated with UV-Visible light filter alone Receives: Drug: Retinoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASI score
Melasma Activity and Severity Index
Measured: 3 months
Secondary outcomes (1)
Opsin receptors
Relative Expression of the opsin receptors by RT-qPCR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start31 Jan 2019
- Primary completion30 Sep 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417348
- Sponsor's protocol ID
- OPN3Mel
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28842328Ozdeslik 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.
PubMed 31097585
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Opsins Receptors in Melasma and Its Modification With UV-Visible Light Sunscreen and 0.05% Retinoic Acid.
- ClinicalTrials.gov ID
- NCT04417348
- Acronym / sponsor ID
- OPN3Mel
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone
| Arm | Type | Receives |
|---|---|---|
| Retinoic Acid | Active comparator | Drug: Retinoic acidpatients with melasma treated with 0.05% retinoic acid plus UV-Visible light filter |
| Sunscreen | Placebo comparator | Drug: Retinoic acidpatients with melasma treated with UV-Visible light filter alone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinoic acidTo 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 | Drug | Retinoic Acid, Sunscreen |
Primary outcome
MASI score
Time frame: 3 months
Melasma Activity and Severity Index
1 secondary outcome
Opsin receptors
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 28842328Regazzetti 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 publication: PubMed 31097585Ozdeslik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinoic acid in people with Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MASI score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417348, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020; AzTrials last refreshed its copy on 27 Oct 2026.