Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000548437
Ethics application status
Approved
Date submitted
12/01/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of efficacy of exosomes vs platelet rich plasma therapy in treatment of androgenetic alopecia
Scientific title
Comparison of efficacy of exosomes vs platelet rich plasma therapy in treatment of androgenetic alopecia
Secondary ID [1] 313686 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic alopecia 336259 0
Condition category
Condition code
Skin 332803 332803 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to compare the efficacy of exosomes versus PRP in the treatment of Androgenetic alopecia by using photographic assessment, hair pull test and patient self-assessment questionnaire over a period of 6 months.
The enrolled patients will be randomly divided into two groups using the lottery method, Group A and B, each with 40 participants.
GROUP A:
Group A will receive treatment with exosomes intradermally at 0,1 and 3 months. Exosomes used are GFC CELL, consist of Leucoexo 97% having GFC CELL EXO SCALP 9700 powder and EXO SCALP Pep9 solution. The scalp will be cleaned with spirit and nerve block will be given by using the local injection, lignocaine, by insulin syringe at supratrochlear, supraorbital, and occipital region. Exosomes will then be injected at a strength of 2 to 10 billion particles/5ml, at a dose of 0.1 ml/cm2 of scalp. Patients will be observed for 1-hour post procedure for any adverse effects and will be instructed not to wash or massage their hair and avoid heavy activities for 48 hours after the injection.

Exosomes will be administered by Dermatologist in the dermatology clinic, Combined Military Hospital, Quetta.
Participants will be assessed at 0,1, 3, and 6 months. Serial photographs will be taken at each assessment. The efficacy of both groups will be evaluated using the hair pull test, global photography, patient and physician satisfaction questionnaire.
Intervention code [1] 330281 0
Treatment: Other
Comparator / control treatment
GROUP B:
Group B will receive monthly injections of Platelet Rich Plasma (PRP) for 6 months Before the treatment, patient will be instructed to clean the scalp and not apply any oil to their scalp. The scalp will be cleaned and nerve block would be administered. Under aseptic conditions, around 30ml of blood will be collected from the median cubital vein and transferred into a tube containing anticoagulant sodium citrate, blood will then be subjected to a soft spin at 1500 RPM for 10 minutes in a centrifuge machine which will separate the blood into 2 layers: the lower RBC layer; the upper plasma layer buffy coat. This tube will again be subjected to a second centrifugation at 3000 RPM for 10 minutes, allowing the platelet rich plasma to settle. Upper layer of platelet poor plasma and the lower layer of the PRP will be collected. PRP will be extracted in sterile insulin syringes and will be activated using calcium gluconate in a ratio of 1:9 and administered intradermally in doses of 0.1 to 0.2 ml each, spaced 1 cm apart, in inter follicular areas. Platelet poor plasma will then be sprinkled and lightly massaged at all administration sites.

Blood will be withdrawn 1 hour before administration of PRP on the same day. PRP will be administered by Dermatologist in the dermatology clinic, Combined Military Hospital, Quetta.
Participants will be assessed at 0,1, 3, and 6 months. Serial photographs will be taken at each assessment. The efficacy of both groups will be evaluated using the hair pull test, global photography, patient and physician satisfaction questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 340330 0
Hair Loss
Timepoint [1] 340330 0
Group A will be assessed at 0,1 and 3 months Group B will be assessed monthly for 6 months
Primary outcome [2] 341213 0
Hair Density
Timepoint [2] 341213 0
Group A will be assessed at 0,1 and 3 months Group B will be assessed monthly for 6 months
Secondary outcome [1] 443725 0
Hair Growth
Timepoint [1] 443725 0
Group A will be assessed at 0,1 and 3 months Group B will be assessed monthly for 6 months

Eligibility
Key inclusion criteria
Inclusion criteria
Clinical diagnosis of AGA
Age range of 18-60 years
Platelets count more than 150, 000 /µl to 450,000/ µl
Patients with Hamilton-Norwood Grade 2-5 or Ludwig scale Grade 1-3
Patients who haven’t received topical or systemic treatments for AGA within 3 months prior to the study
Patient who gave consent for the study
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Patients with other causes of hair loss fungal infection such as fungal infection, inflammatory or scarring alopecia, hyper-androgenism, telogen effluvium or other hormonal disorders
Patients with history of severe systemic disease (renal, cardiovascular hepatic and lungs) or active cancers
Pregnant or breastfeeding patients
Patients having known hypersensitivity to exosomes
Patients that are immunodeficient or are undergoing immunosuppressive therapy
Patients on anticoagulation or having bleeding disorders such as thrombocytopenia and anemia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers were used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will draw a piece of paper from an opaque container to determine which treatment they will be allocated to
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study was calculated using the WHO calculator and following parameters:
Level of significance (a): 5%
Power of the test (1-ß): 80%
Anticipated Population Proportion 1 (P1): (0.743)1
Anticipated Population Proportion 2 (P2): (0.473)8
Sample size (n): 40 in each group
Total sample size for study will be: 80

Demographic data will be summarized using descriptive statistics. Mean and standard deviation were calculated for the quantitative variables like age and the duration of baldness. Frequency and percentage will be calculated for qualitative variables like gender, response to treatment, occurrence of adverse events. The quantitative variables will be compared using an independent t-test, while the qualitative outcome variable will be compared using a Chi-square/Fisher's exact test. The standard for determining statistical significance will be two-sided, p = 0.05. SPSS version 29 will be used to enter and evaluate the data.

Hair Pull Test: The hair pull test is performed 3 times by the same clinician where in a bundle of approximately 50-60 hair is grasped between the thumb, index and
middle finger from the base close to the scalp. The hair is firmly tugged away from the scalp, and the extracted hair is counted in every session. More than six hairs or 10% of the total hair - “positive” Six or less hairs or 50%

Physician Global Assessment
Dermatologist will assess the difference in patients’ hair thickness, growth and hair density by answering a questionnaire with 3 questions. Each question will be statistically relevant and held significant efficacy in determining the outcome of the study. Clinical response will be interpreted as:- No change 0% Fair 0-25% Good 25-50% Excellent >50%

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2025
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
80
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 26815 0
Pakistan
State/province [1] 26815 0
Balochistan

Funding & Sponsors
Funding source category [1] 318150 0
Self funded/Unfunded
Name [1] 318150 0
Dr Maira Wajahat - Combined Military Hospital Quetta
Country [1] 318150 0
Pakistan
Primary sponsor type
Individual
Name
Dr Maira Wajahat - Combined Military Hospital Quetta
Address
Country
Pakistan
Secondary sponsor category [1] 320533 0
Individual
Name [1] 320533 0
DR NAJIA AHMED - Combined Military Hospital Quetta
Address [1] 320533 0
Country [1] 320533 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316795 0
INSTITUTIONAL ETHICAL REVIEW BOARD (IERB) - CMH QUETTA
Ethics committee address [1] 316795 0
Ethics committee country [1] 316795 0
Pakistan
Date submitted for ethics approval [1] 316795 0
21/12/2024
Approval date [1] 316795 0
23/12/2024
Ethics approval number [1] 316795 0
CMH QTA-IERB/60/2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139038 0
Mrs MAIRA WAJAHAT
Address 139038 0
COMBINED MILITARY HOSPITAL QUETTA. MOQ 2/2, Near Mess 10, Chiltan Road, Quetta Cantt, Quetta, Balochistan, Pakistan, Zip Code 87300
Country 139038 0
Pakistan
Phone 139038 0
+923317690447
Fax 139038 0
Email 139038 0
[email protected]
Contact person for public queries
Name 139039 0
MAIRA WAJAHAT
Address 139039 0
COMBINED MILITARY HOSPITAL,QUETTA. MOQ 2/2, Near Mess 10, Chiltan Road, Quetta Cantt, Quetta, Balochistan, Pakistan, Zip Code 87300
Country 139039 0
Pakistan
Phone 139039 0
+923317690447
Fax 139039 0
Email 139039 0
[email protected]
Contact person for scientific queries
Name 139040 0
MAIRA WAJAHAT
Address 139040 0
COMBINED MILITARY HOSPITAL. MOQ 2/2, Near Mess 10, Chiltan Road, Quetta Cantt, Quetta, Balochistan, Pakistan, Zip Code 87300
Country 139040 0
Pakistan
Phone 139040 0
+923317690447
Fax 139040 0
Email 139040 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    New erc maira.pdf
Other    Abbreviated protocol including consent form, data ... [More Details] Draft 1 - Copy 2.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.