Clinical trial NCT06066827: Hair Regeneration in Androgenetic Alopecia
Official title: Hair Regeneration in Androgenetic Alopecia Using Secretome of Adipose-derived Stem Cells (ADSC) and Minoxidil: A Comparative Study of Three Groups
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Androgenetic Alopecia
Keywords: Secretome
Minoxidil
Skin
Androgenetic alopecia
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Culture, Research, and Technology, Republic of Indonesia
name: PT. Kimia Farma (Persero) Tbk
First posted: 2023-10-04
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
Primary purpose: TREATMENT

Brief summary: This clinical trial study aims to compare the effectiveness and safety of secretome from ADSCs with minoxidil in AGA cases, to provide future reference or standard in the application of cell-based therapy and its derivatives in AGA cases. The subject of this study is androgenetic alopecia population. The main questions it aims to answer are:

* Is the secretome of ADSC's effective compared to minoxidil?
* Is the secretome of ADSC's safe compared to minoxidil?
* Is the combination of the secretome of ADSC's and minoxidil better in safety and effectiveness compared to secretome or minoxidil alone?

Detailed description: This study was a single-blind clinical trial using an experimental research design on subjects with androgenetic alopecia. Variables tested in this study were the method of "treatment of AGA by administering secretome concentrate alone, compared to using minoxidil alone and with a combination of both."

Subjects were divided into 3 groups:

* 20 subjects received secretome
* 20 subjects received minoxidil
* 20 subjects received both treatments Participants will undergo history taking, and a physical examination (including vital signs, body weight, and hair pull test). Pictures of patients' head were then taken and the hair loss degree was graded using Hamilton-Norwood. Hair growth was evaluated every month starting from months 0, 1, 2, and 3. Clinical assessment of hair growth was examined through physical and supporting examinations including photography, trichoscan, and trichoscopy.

The sample size for this study was calculated with the help of G\*Power version 3.1 software (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany).

The inclusion and exclusion criteria are applied. Statistical data were analyzed using SPSS® version 21 software. On numerical data, normality analysis was carried out using the Kolmogorov-Smirnov test.

Eligibility criteria: Inclusion Criteria:

* Male patients aged 18-59 years
* Clinical presentation of AGA with Hamilton-Norwood Grade III-VI
* Willing to be a research subject, sign a consent form, and commit to regular follow-up visits

Exclusion Criteria:

* Hair loss other than AGA, including telogen effluvium, alopecia areata, trichotillomania, secondary syphilis, systemic lupus erythematosus hair loss due to chemotherapy, autoimmune conditions, or malignancies.
* Patients taking oral medications or vitamins aimed at increasing hair growth in the last month
* Patients applying topical medications aimed at increasing hair growth in the last 2 weeks
* Patients with active bacterial, viral, or fungal infections on the scalp
* Patients undergoing AGA therapy cosmetic procedures in the form of PRP injections, laser procedures, or micro-needling in the last 3 months

Primary outcomes:
measure: Improvement of alopecia in physical examination
timeFrame: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
measure: Macroscopic hair growth documented
timeFrame: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
measure: Microscopic hair growth evaluated by Trichoscopy
timeFrame: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
measure: Microscopic hair growth evaluated by Trichoscan
timeFrame: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Week 12 (end of trial)
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUP Nasional Cipto Mangunkusumo
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Jakarta
Study officials:
References: