Clinical trial NCT01701271: Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Keywords: Baldness
Androgenetic Alopecia
Alopecia
Lead sponsor: Mexis George
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  1. The pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology.
  2. A sebum-meter to check the presence of scales on the scalp.
  3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change of the Amount of Hair Loss in a Pull Test
timeFrame: baseline and 90 days
measure: Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
timeFrame: baseline and 90 days
Secondary outcomes:
measure: Change of Sebum on a Sebum-meter
timeFrame: baseline and 90 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: George Mexis
Study officials:
affiliation: Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation
name: Fulvio Marzatico, Monitor
role: STUDY_CHAIR
References: