ChloasmaNCT03618277
Identification of Biomarkers and Characterization of Melasma
A study testing Biopsy in people with Chloasma, run by Pierre Fabre Dermo Cosmetique.
Trial summary
Melasma (also called chloasma and pregnancy mask) is characterized by pigmented lesions darker than their usual complexion on the faces of affected subjects. The physiopathology of melasma is still poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Chloasma
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2018to 10 Oct 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Woman aged 18 to 60 years old included
- Phototype III to IV included according to Fitzpatrick classification
- Informed consent signature
- Subject accepting micro-biopsies on study areas
- Subject with melasma lesions in the face of moderate to severe intensity defined by clinical rating (Physician Global Assesment Static) allowing the realization of micro-biopsies according to the opinion of the investigator
Who cannot join
- Subject having planned to stay more than 7 consecutive days in a place with a significant increase in the UV index (ski holidays, travel to the tropics, etc.)
- Subject with pigmented facial lesions other than those related to melasma.
- Subject having already presented cicatrization disorders
- Subject having undergone a physical treatment (radiotherapy ...) on the face, during the last 6 months or planned during the study
- Chemical peel, laser treatment or dermabrasion, performed on the face in the 3 months preceding the inclusion visit,
- Application of medication containing hydroquinone or other depigmenting treatments (retinoids, topical steroids) applied to the face in the 2 months prior to the inclusion visit,
- Applying depigmenting cosmetic products to the face within 4 weeks prior to the inclusion visit
About this study
Official title: Identification of Biological Markers and Biometrological Characterization of Melasma
Melasma (also called chloasma and pregnancy mask) is characterized by pigmented lesions darker than their usual complexion on the faces of affected subjects.
The physiopathology of melasma is still poorly understood. To date, the factors that favor the onset of melasma appear to be: genetic predisposing factors, changes in sex hormone levels, and sun exposure.
Read more
Vascularization as well as elastosis also appear to be increased in skin with melasma.
The aim of this study is to evaluate the different levels of expression of biomarkers between pigmented melasma lesions and surrounding healthy skin when melasma is highly pigmented but also when it is dormant (ie treated melasma, without UV solicitation in the heart of winter). The goal is to identify and better understand the involvement of different genes and proteins and thus offer more specific ways of care, and therefore effective, for the subjects.
- Conditions
- Chloasma
- Being tested
- Biopsy
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Photography
Micro-biopsies will be performed using a punch of 1 mm in diameter, by pulling the skin at the time of sampling, after disinfection and anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intra individual | Other | Before and after being treated by a product (outside the study) Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies
The expression levels of the biomarkers (transcriptomic and proteomic) of each zone will be measured and compared.
Transcriptomic analysis will be performed by biochip. Proteomic analysis will be performed by mass spectroscopy.
Measured: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
Change from baseline at Visite 2 : Photographic evaluation of melasma
From photographs, the severity of the lesions will be evaluated.
Measured: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
Change from baseline at Visite 2 : Clinical evaluation of melasma by P.G.A. scales
Different intensities of melasma will be evaluated by clinical rating : Physician Global Assessment (PGA) Static (4-point scale) and Dynamic (7-point scale).
Measured: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start10 Oct 2018
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Why it stopped: business strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChloasmaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier COUSTOU, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618277
- Sponsor's protocol ID
- MELASMAPHYSIOBIOMETRO
- Status last verified
- Aug 2018
- First submitted
- 26 Jul 2018
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biological Markers and Biometrological Characterization of Melasma
- ClinicalTrials.gov ID
- NCT03618277
- Acronym / sponsor ID
- MELASMAPHYSIOBIOMETRO
- Conditions
- Chloasma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: business strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 7 Aug 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.
Melasma (also called chloasma and pregnancy mask) is characterized by pigmented lesions darker than their usual complexion on the faces of affected subjects.
The physiopathology of melasma is still poorly understood. To date, the factors that favor the onset of melasma appear to be: genetic predisposing factors, changes in sex hormone levels, and sun exposure.
Vascularization as well as elastosis also appear to be increased in skin with melasma.
The aim of this study is to evaluate the different levels of expression of biomarkers between pigmented melasma lesions and surrounding healthy skin when melasma is highly pigmented but also when it is dormant (ie treated melasma, without UV solicitation in the heart of winter). The goal is to identify and better understand the involvement of different genes and proteins and thus offer more specific ways of care, and therefore effective, for the subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra individual | Other | Procedure: BiopsyBefore and after being treated by a product (outside the study) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Woman aged 18 to 60 years old included
- Phototype III to IV included according to Fitzpatrick classification
- Informed consent signature
- Subject accepting micro-biopsies on study areas
- Subject with melasma lesions in the face of moderate to severe intensity defined by clinical rating (Physician Global Assesment Static) allowing the realization of micro-biopsies according to the opinion of the investigator
Key exclusion criteria (7 listed)
- Subject having planned to stay more than 7 consecutive days in a place with a significant increase in the UV index (ski holidays, travel to the tropics, etc.)
- Subject with pigmented facial lesions other than those related to melasma.
- Subject having already presented cicatrization disorders
- Subject having undergone a physical treatment (radiotherapy ...) on the face, during the last 6 months or planned during the study
- Chemical peel, laser treatment or dermabrasion, performed on the face in the 3 months preceding the inclusion visit,
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 |
|---|---|---|
| BiopsyAlso: PhotographyMicro-biopsies will be performed using a punch of 1 mm in diameter, by pulling the skin at the time of sampling, after disinfection and anesthesia. | Procedure or surgery | Intra individual |
Primary outcome
Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies
Time frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
The expression levels of the biomarkers (transcriptomic and proteomic) of each zone will be measured and compared. Transcriptomic analysis will be performed by biochip. Proteomic analysis will be performed by mass spectroscopy.
Change from baseline at Visite 2 : Photographic evaluation of melasma
Time frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
From photographs, the severity of the lesions will be evaluated.
Change from baseline at Visite 2 : Clinical evaluation of melasma by P.G.A. scales
Time frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
Different intensities of melasma will be evaluated by clinical rating : Physician Global Assessment (PGA) Static (4-point scale) and Dynamic (7-point scale).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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.
Didier COUSTOU, Dr principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Chloasma, run by Pierre Fabre Dermo Cosmetique.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Jan 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies (time frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)). The study lists 3 primary outcomes in all. 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 22 Jan 2020.