MelasmaEarly Phase 1NCT03392623
DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
A Early Phase 1 study testing Retinoic acid, colorimetry measurement and sunscreen in people with Melasma, run by Universidad Autonoma de San Luis Potosí.
Trial summary
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Retinoic acid, colorimetry measurement and sunscreen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Dec 2016
- Phase
- Early Phase 1
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.
Who cannot join
- Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver).
- Have received treatment in the last 2 months. Regular use of sunscreen.
About this study
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
Read the detailed description
OBJECTIVE: Recognize the DNA methylation status of the malar melasma and perilesional skin, and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025% retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real time-PCR (polymerase chain reaction amplification), immunohistochemistry and immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated compared with unaffected skin in all subjects indicating hypermethylation of DNA. Hypermethylation decreased by S (7 vs 3 times relative expression, p<0.05), RA (7 vs 2 times relative expression p<0.05), and N (7 vs 1 relative expression p<0.01) correlated with clinical improvement, this was also supported by immunohistochemistry and immunofluorescence. CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions. Environmental factors such as sun radiation may induce DNA hypermethylation triggering hyperpigmentation trough the activation of pathways regulated by epigenetic modifications. Thus, decreasing methylation by sunscreen protection and the genetic transcription modification through N and RA, may allow their clinical improvement regardless its depigmenting effect.
- Conditions
- Melasma
- Being tested
- Retinoic acid, colorimetry measurement, sunscreen, Niacinamide
- Keywords
- Epigenetics, Malar melasma,
- 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
Also called Niacinamide, Sunscreen
topical administration in melasma lesions
colorimetry measurementDevice
Measurement of erythema and luminosity through a colorimeter
sunscreenDrug
topical administration in melasma lesions
NiacinamideDrug
topical administration in melasma lesions
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Macules of melasma without any treatment Receives: Device: colorimetry measurement |
| Niacinamide group | Experimental | Macules of melasma treated with topical Niacinamide cream 4% for 8 weeks Receives: Device: colorimetry measurement; Drug: Niacinamide |
| Retinoic acid group | Experimental | Macules of melasma treated with topical retinoic acid 0.05% for 8 weeks Receives: Drug: Retinoic acid; Device: colorimetry measurement |
| Sunscreen group | Placebo comparator | Macules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks Receives: Device: colorimetry measurement; Drug: sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve in the level of DNA methylated
Decrease in levels of expression of DNA methyl transferases
Measured: 8 weeks
Secondary outcomes (1)
improve in the clinical severity of melasma
decrease in the MASI score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392623
- Sponsor's protocol ID
- 71-15
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2018
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
- ClinicalTrials.gov ID
- NCT03392623
- Acronym / sponsor ID
- 71-15
- Conditions
- Melasma
- Keywords
- Epigenetics, Malar melasma,
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 8 Jan 2018 (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.
BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.
Detailed description
OBJECTIVE: Recognize the DNA methylation status of the malar melasma and perilesional skin, and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025% retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real time-PCR (polymerase chain reaction amplification), immunohistochemistry and immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated compared with unaffected skin in all subjects indicating hypermethylation of DNA. Hypermethylation decreased by S (7 vs 3 times relative expression, p<0.05), RA (7 vs 2 times relative expression p<0.05), and N (7 vs 1 relative expression p<0.01) correlated with clinical improvement, this was also supported by immunohistochemistry and immunofluorescence. CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions. Environmental factors such as sun radiation may induce DNA hypermethylation triggering hyperpigmentation trough the activation of pathways regulated by epigenetic modifications. Thus, decreasing methylation by sunscreen protection and the genetic transcription modification through N and RA, may allow their clinical improvement regardless its depigmenting effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: colorimetry measurementMacules of melasma without any treatment |
| Niacinamide group | Experimental | Device: colorimetry measurement, Drug: NiacinamideMacules of melasma treated with topical Niacinamide cream 4% for 8 weeks |
| Retinoic acid group | Experimental | Drug: Retinoic acid, Device: colorimetry measurementMacules of melasma treated with topical retinoic acid 0.05% for 8 weeks |
| Sunscreen group | Placebo comparator | Device: colorimetry measurement, Drug: sunscreenMacules of melasma treated with sunscreen cream with a 50 sun protection factor for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.
Key exclusion criteria (2 listed)
- Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver).
- Have received treatment in the last 2 months. Regular use of sunscreen.
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 acidAlso: Niacinamide, Sunscreentopical administration in melasma lesions | Drug | Retinoic acid group |
| colorimetry measurementMeasurement of erythema and luminosity through a colorimeter | Device | Control group, Niacinamide group, Retinoic acid group, Sunscreen group |
| sunscreentopical administration in melasma lesions | Drug | Sunscreen group |
| Niacinamidetopical administration in melasma lesions | Drug | Niacinamide group |
Primary outcome
improve in the level of DNA methylated
Time frame: 8 weeks
Decrease in levels of expression of DNA methyl transferases
1 secondary outcome
improve in the clinical severity of melasma
Time frame: 8 weeks
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 9 Jan 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Retinoic acid, colorimetry measurement and sunscreen in people with Melasma, run by Universidad Autonoma de San Luis Potosí.
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 2 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
improve in the level of DNA methylated (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.