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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01643629
Other study ID # KRPL/HPL-AGA/11-12/001A
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received July 12, 2012
Last updated July 24, 2012
Start date January 2012
Est. completion date November 2012

Study information

Verified date July 2012
Source Kasiak Research Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Caliber & Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date November 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Male subjects, aged between 18 to 50 years (both inclusive) and in general good health

- Subjects willing to refrain from other AGA treatments during the entire study duration

- Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

- Subjects aged <18 or > 50 years

- Subjects with dermatological disorder of scalp that might interfere with study evaluation

- Subjects on Anti-coagulant therapy

- Subjects with clinically significant medical or psychiatric disease as determined by the investigator.

- Subjects with dermatological disorder of scalp that might interfere with study evaluation

- Subjects unwilling to or unable to comply with the study protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Autologous Human Platelet Lysate (HPL)
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
Other:
2 % Minoxidil and /or Finasteride
Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

Locations

Country Name City State
India Kasiak Research Pvt Ltd Thane Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Kasiak Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Other Physician's Assessment Score End of study - Month 6 No
Other Patient's Assessment Score End of study - Month 6 No
Primary Change in Calibre & Density of Hair as assessed by Folliscope Day 0, Month 4, End of study - Month 6 No
Secondary Photographic Assessment Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 No
See also
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