MelasmaNCT02061839
Prevention of Melasma Relapse During Summertime
A study testing Sunscream with visible light protection and Sunscream in people with Melasma, run by Centre de Pharmacologie Clinique Applique a la Dermatologie.
Trial summary
Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Sunscream with visible light protection and Sunscream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 2013
- 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
- Melasma
Who cannot join
- Other pigmentary disorders associated (including PIH)
About this study
Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.
Read the detailed description
40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).
There will be 3 visits: Baseline, T2.5months and T5months (final visit).
Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.
Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.
- Conditions
- Melasma
- Being tested
- Sunscream with visible light protection, Sunscream
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscream with visible light protectionOther
SunscreamOther
| Study group | Role | What they receive |
|---|---|---|
| Teinted sunscream | Experimental | UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator) Receives: Other: Sunscream with visible light protection |
| Regular sunscream | Active comparator | UVA and UVB protection Receives: Other: Sunscream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between MASI scores before prevention treatment and after 6 months
MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionOct 2013
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Pharmacologie Clinique Applique a la Dermatologie
- Sponsor type
- University, hospital or other
- Collaborators
- BIODERMA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061839
- Sponsor's protocol ID
- 2013-A00073-42
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2014
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Melasma Relapse During Summertime
- ClinicalTrials.gov ID
- NCT02061839
- Acronym / sponsor ID
- 2013-A00073-42
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre de Pharmacologie Clinique Applique a la DermatologieUniversity, hospital or other
- Collaborators
- BIODERMA
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Feb 2014 (estimated)
- 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.
Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.
Detailed description
40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).
There will be 3 visits: Baseline, T2.5months and T5months (final visit).
Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.
Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teinted sunscream | Experimental | Other: Sunscream with visible light protectionUVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator) |
| Regular sunscream | Active comparator | Other: SunscreamUVA and UVB protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Melasma
Key exclusion criteria (1 listed)
- Other pigmentary disorders associated (including PIH)
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 |
|---|---|---|
| Sunscream with visible light protection | Other | Teinted sunscream |
| Sunscream | Other | Regular sunscream |
Primary outcome
Comparison between MASI scores before prevention treatment and after 6 months
Time frame: 6 months
MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period
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 13 Feb 2014.
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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 study testing Sunscream with visible light protection and Sunscream in people with Melasma, run by Centre de Pharmacologie Clinique Applique a la Dermatologie.
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 13 Feb 2014. 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. 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?
Comparison between MASI scores before prevention treatment and after 6 months (time frame: 6 months). 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 13 Feb 2014.