MelasmaGlisodinNCT03878433
Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.
A study testing Glisodin in people with Melasma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Glisodin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 1 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed melasma in adult patient
- signed inform consent
Who cannot join
- Pregnant women
- Other pigmentary disorder of the afce
- Use of depigmentant agent in the month before the inclusion
- Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion
- Coeliac disease or allergy to gluten
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study
Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.
- Conditions
- Melasma
- Being tested
- Glisodin, placebo
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlisodinDrug
500 mg/day between 12 weeks
placeboOther
Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Drug | Active comparator | Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast Receives: Drug: Glisodin |
| No Drug | Placebo comparator | 2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of melasma
Change from Baseline of the Modified Melasma Area and Severity Index (mMASI) total score at 12 months. The MASI is 0 à 24 : Front 0.3(D)(A)+ right malar 0.30(D)(A)+ left malar 0.30(D)(A)+ chin 0.1(D)(A)
Measured: At baseline and at 12 weeks
Secondary outcomes (2)
Quality of life of patient: VAS (Visual Analog Scale)
Change from Baseline of quality of life at 12 months (Visual Analog Scale with a graduation from 0 to 10)
Measured: At baseline and at 12 weeks
Satisfaction of the patients: VAS (Visual Analog Scale)
Change from Baseline of satisfaction of the patients total score at 12 months (Visual Analog Scale with a graduation from 0 to 10)
Measured: At baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Jan 2020
- Study completion1 Jul 2020
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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, Dermatologie, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878433
- Sponsor's protocol ID
- 18-PP-02
- Acronym
- Glisodin
- Status last verified
- Sep 2021
- First submitted
- 25 Jan 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03878433
- Acronym / sponsor ID
- Glisodin / 18-PP-02
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Mar 2019 (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.
Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Active comparator | Drug: GlisodinGlisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast |
| No Drug | Placebo comparator | Other: placebo2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed melasma in adult patient
- signed inform consent
Key exclusion criteria (5 listed)
- Pregnant women
- Other pigmentary disorder of the afce
- Use of depigmentant agent in the month before the inclusion
- Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion
- Coeliac disease or allergy to gluten
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 |
|---|---|---|
| Glisodin500 mg/day between 12 weeks | Drug | Drug |
| placeboPlacebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months | Other | No Drug |
Primary outcome
Severity of melasma
Time frame: At baseline and at 12 weeks
Change from Baseline of the Modified Melasma Area and Severity Index (mMASI) total score at 12 months. The MASI is 0 à 24 : Front 0.3(D)(A)+ right malar 0.30(D)(A)+ left malar 0.30(D)(A)+ chin 0.1(D)(A)
2 secondary outcomes
Quality of life of patient: VAS (Visual Analog Scale)
Time frame: At baseline and at 12 weeks
Satisfaction of the patients: VAS (Visual Analog Scale)
Time frame: At baseline and at 12 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 14 Sep 2021.
- 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.
Passeron Thierry, PhD principal investigator
Dermatologie, CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glisodin in people with Melasma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 inclusion and 5 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 14 Sep 2021. 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 France. 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?
Severity of melasma (time frame: At baseline and at 12 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 14 Sep 2021.