NCT01701271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2001

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 17, 2016

Completed
Last Updated

February 17, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

October 1, 2012

Results QC Date

September 13, 2013

Last Update Submit

January 20, 2016

Conditions

Keywords

BaldnessAndrogenetic AlopeciaAlopecia

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    baseline and 90 days

Secondary Outcomes (1)

  • Change of Sebum on a Sebum-meter

    baseline and 90 days

Study Arms (1)

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

Other: Hair loss prevention lotion

Interventions

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.

Volunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Illness
  • Good state of hair
  • Pharmacological treatment in progress
  • Denial of the continuance of the usual daily routine
  • Atopy in the anamnesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Mexis

Athens, 11253, Greece

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Fulvio Marzatico
Organization
Bio Basic Europe

Study Officials

  • Fulvio Marzatico, Monitor

    Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 5, 2012

Study Start

February 1, 2001

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

February 17, 2016

Results First Posted

February 17, 2016

Record last verified: 2016-01

Locations