Androgenetic AlopeciaMEXISPATENTNCT01701271
Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females
A study testing Hair loss prevention lotion in people with Androgenetic Alopecia, 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 Androgenetic Alopecia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Hair loss prevention lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2001to Jun 2001
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good state of general health
- Suffering from hair loss
- 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.
About this study
Official title: Evaluation of the Efficacy of the Cosmetic Lotion M.P.A.F. (Mixture of Paraffin, Alcohol and Fur) MEXIS PATENT in the Treatment of Androgenetic Alopecia by Decreasing of Hair Loss and Strengthening and Thickening of Hair in Males and Females.
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 Androgenetic Alopecia.
Read the detailed description
This study verifies whether the tested product has any efficacy in the treatment of Androgenetic Alopecia.
- 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 have been selected for this test .
- Samples of the product have been applied following their usual use: as they are.
- On the selecting volunteers have been used:
- The pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology.
- A sebum-meter to check the presence of scales on the scalp.
- A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.
- Volunteers were also asked about:
- Fluffiness
- Sheen
- Itching
- Presence of scales on scalp
- Oily hair
- Product's acceptability
- The readings are 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 were taken during experimentation.
- Conditions
- Androgenetic Alopecia
- Being tested
- Hair loss prevention lotion
- Keywords
- Baldness, Androgenetic Alopecia, Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair loss prevention lotionOther
For greatest problems 20 drops on the scalp per day for 3 months. For minor problems 10 drops on the scalp three times per week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Experimental | 20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Allopecia in several types apply on the scalp drops of the hair loss prevention lotion Receives: Other: Hair loss prevention lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Amount of Hair Loss in a Pull Test
Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair
Measured: baseline and 90 days
Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments
Measured: baseline and 90 days
Secondary outcomes (1)
Change of Sebum on a Sebum-meter
Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.
Measured: baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startFeb 2001
- Primary completionJun 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Androgenetic AlopeciaStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Mexis George
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fulvio Marzatico, Monitor, Study chair, Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701271
- Sponsor's protocol ID
- MEXIS-HAIR LOSS-STUDY 1.2012
- Acronym
- MEXISPATENT
- Status last verified
- Jan 2016
- First submitted
- 1 Oct 2012
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Cosmetic Lotion M.P.A.F. (Mixture of Paraffin, Alcohol and Fur) MEXIS PATENT in the Treatment of Androgenetic Alopecia by Decreasing of Hair Loss and Strengthening and Thickening of Hair in Males and Females.
- ClinicalTrials.gov ID
- NCT01701271
- Acronym / sponsor ID
- MEXISPATENT / MEXIS-HAIR LOSS-STUDY 1.2012
- Conditions
- Androgenetic Alopecia
- Keywords
- Baldness, Androgenetic Alopecia, Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mexis GeorgeUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Posted 17 Feb 2016
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 Androgenetic Alopecia.
Detailed description
This study verifies whether the tested product has any efficacy in the treatment of Androgenetic Alopecia.
- 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 have been selected for this test .
- Samples of the product have been applied following their usual use: as they are.
- On the selecting volunteers have been used:
- The pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology.
- A sebum-meter to check the presence of scales on the scalp.
- A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.
- Volunteers were also asked about:
- Fluffiness
- Sheen
- Itching
- Presence of scales on scalp
- Oily hair
- Product's acceptability
- The readings are 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 were 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 | Experimental | Other: Hair loss prevention lotion20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Allopecia in several types apply on the scalp drops of the hair loss prevention lotion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good state of general health
- Suffering from hair loss
- 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 |
|---|---|---|
| Hair loss prevention lotionFor greatest problems 20 drops on the scalp per day for 3 months. For minor problems 10 drops on the scalp three times per week for 3 months. | Other | Volunteers |
Primary outcome
Change of the Amount of Hair Loss in a Pull Test
Time frame: baseline and 90 days
Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers. Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair
Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
Time frame: baseline and 90 days
Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments
1 secondary outcome
Change of Sebum on a Sebum-meter
Time frame: baseline and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
Fulvio Marzatico, Monitor study chair
Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair loss prevention lotion in people with Androgenetic Alopecia, 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: finished, as of the sponsor's last update on 17 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of the Amount of Hair Loss in a Pull Test (time frame: baseline and 90 days). The study lists 2 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 17 Feb 2016.