A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia

NCT01643629 | Unknown Phase 1 DMC

• 1 other identifier: KRPL/HPL-AGA/11-12/001A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Change in Calibre & Density of Hair as assessed by Folliscope

  Day 0, Month 4, End of study - Month 6

Secondary Outcomes (1)

• Photographic Assessment

  Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6

Other Outcomes (2)

• Physician's Assessment Score

  End of study - Month 6

• Patient's Assessment Score

  End of study - Month 6

Study Arms (2)

Study arm A

OTHER

Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.

Biological: Autologous Human Platelet Lysate (HPL)

Control Arm B

OTHER

Control arm B will include subjects receiving Standard therapy

Other: 2 % Minoxidil and /or Finasteride

Interventions

Autologous Human Platelet Lysate (HPL) BIOLOGICAL

Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.

Study arm A

2 % Minoxidil and /or Finasteride OTHER

Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

Control Arm B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.: lead

Study Sites (1)

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Finasteride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Rajendarsingh Rajput, Dr.

  Dr. Rajesh Rajput Hair Restore

  PRINCIPAL INVESTIGATOR

• Sandeep Sattur, Dr.

  Hairrevive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 18, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

IN (1)