Alopecia AreataMEXISAREATANCT02604888
Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females
A study testing MEXIS/M6S Patent - lotion against alopecia in people with Alopecia Areata, run by Mexis George at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- MEXIS/M6S Patent - lotion against alopecia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2015to Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good state of general health
- Suffering from Alopecia Areata
- No pharmacological treatment in progress
- Promise not to change the usual daily routine
- No atopy in the anamnesis
Who cannot join
- Illness
- Good state of hair
- Pharmacological treatment in progress
- Denial of the continuance of the usual daily routine
- Atopy in the anamnesis
Trial locations and contacts
1 site in 1 country.
Sandy Matzakoni, Controller contact
Greece1 site, 1 recruiting
- Recruiting
George Mexis
Athens, 11253
Matzakonis Sandy, Supervisor, 2108623547 ext. 0030, info@mexis.gr
Markos Papakonstantis, Controller
About this study
The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.
Read the detailed description
This study verifies whether the tested product has any efficacy in the treatment of Alopecia Areata.
- The evaluated product (Hair Loss prevention Lotion) is called: MEXIS, MPAF, M6S PATENT.
- 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years will be selected for this test .
- Samples of the product have been applied following their usual use: as they are.
- On the selecting volunteers will be used:
A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.
- Volunteers will also be asked about:
- Fluffiness
- Sheen
- Itching
- Presence of scales on scalp
- Oily hair
- Product's acceptability
- The readings will be taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. Then they analyzed and reported in a graph.
- Summarizing tables and graphs of the data will be taken during experimentation.
- Conditions
- Alopecia Areata
- Being tested
- MEXIS/M6S Patent - lotion against alopecia
- Keywords
- Baldness, Alopecia Areata, Alopecia, Hair loss
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEXIS/M6S Patent - lotion against alopeciaOther
For greatest problems 20 drops on the scalp per day for 6 months. For minor problems 10 drops on the scalp three times per week for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Other | 20 volunteers both men and women with an age between 18 and 70 years suffering from Alopecia Areata in several types apply on the scalp drops of the MEXIS/M6S PATENT - lotion against Alopecia Receives: Other: MEXIS/M6S Patent - lotion against alopecia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Density of the Hair measured with a camera
Change on the total amount of head's hair
Measured: baseline and 180 days
Secondary outcomes (1)
Change of the Amount of Hair Loss
Change on the amount of hair fallen per day
Measured: baseline and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mexis George
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markos Papakonstantis, Monitor, Study chair, 401 General Military Hospital of Athens, Dermatology clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604888
- Sponsor's protocol ID
- MEXIS-ALOPECIA AREATA-2015
- Acronym
- MEXISAREATA
- Status last verified
- Jan 2017
- First submitted
- 9 Nov 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females
- ClinicalTrials.gov ID
- NCT02604888
- Acronym / sponsor ID
- MEXISAREATA / MEXIS-ALOPECIA AREATA-2015
- Conditions
- Alopecia Areata
- Keywords
- Baldness, Alopecia Areata, Alopecia, Hair loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mexis GeorgeUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 16 Nov 2015 (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.
The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.
Detailed description
This study verifies whether the tested product has any efficacy in the treatment of Alopecia Areata.
- The evaluated product (Hair Loss prevention Lotion) is called: MEXIS, MPAF, M6S PATENT.
- 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years will be selected for this test .
- Samples of the product have been applied following their usual use: as they are.
- On the selecting volunteers will be used:
A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.
- Volunteers will also be asked about:
- Fluffiness
- Sheen
- Itching
- Presence of scales on scalp
- Oily hair
- Product's acceptability
- The readings will be taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. Then they analyzed and reported in a graph.
- Summarizing tables and graphs of the data will be taken during experimentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Other | Other: MEXIS/M6S Patent - lotion against alopecia20 volunteers both men and women with an age between 18 and 70 years suffering from Alopecia Areata in several types apply on the scalp drops of the MEXIS/M6S PATENT - lotion against Alopecia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good state of general health
- Suffering from Alopecia Areata
- No pharmacological treatment in progress
- Promise not to change the usual daily routine
- No atopy in the anamnesis
Key exclusion criteria (5 listed)
- Illness
- Good state of hair
- Pharmacological treatment in progress
- Denial of the continuance of the usual daily routine
- Atopy in the anamnesis
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 |
|---|---|---|
| MEXIS/M6S Patent - lotion against alopeciaFor greatest problems 20 drops on the scalp per day for 6 months. For minor problems 10 drops on the scalp three times per week for 6 months. | Other | Volunteers |
Primary outcome
Change of the Density of the Hair measured with a camera
Time frame: baseline and 180 days
Change on the total amount of head's hair
1 secondary outcome
Change of the Amount of Hair Loss
Time frame: baseline and 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: Yes
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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.
Sandy Matzakoni, Controller contact
Markos Papakonstantis, Monitor study chair
401 General Military Hospital of Athens, Dermatology clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEXIS/M6S Patent - lotion against alopecia in people with Alopecia Areata, run by Mexis George at 1 site in Greece.
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 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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 Greece. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Matzakoni, Controller (info@mexis.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Density of the Hair measured with a camera (time frame: baseline and 180 days). 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 4 Jan 2017.