Trial Outcomes & Findings for Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females (NCT NCT01701271)
NCT ID: NCT01701271
Last Updated: 2016-02-17
Results Overview
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
COMPLETED
NA
20 participants
baseline and 90 days
2016-02-17
Participant Flow
The recruitment started on February 2001 at the University of studies of Pavia
Participant milestones
| Measure |
Volunteers Evaluated
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females
Baseline characteristics by cohort
| Measure |
Volunteers
n=20 Participants
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 26 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and 90 daysPopulation: 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
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
Outcome measures
| Measure |
Volunteers
n=20 Participants
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
|
|---|---|
|
Change of the Amount of Hair Loss in a Pull Test
|
2.75 Fallen hair
Interval 0.0 to 4.0
|
PRIMARY outcome
Timeframe: baseline and 90 daysPopulation: 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
Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments
Outcome measures
| Measure |
Volunteers
n=20 Participants
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
|
|---|---|
|
Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
|
2.75 hairs/square inch
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: baseline and 90 daysPopulation: Good state of general health Suffering from hair loss
Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.
Outcome measures
| Measure |
Volunteers
n=20 Participants
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
|
|---|---|
|
Change of Sebum on a Sebum-meter
|
8.8 mg sebum/c^2
Interval 0.0 to 30.0
|
Adverse Events
Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place