Androgenetic Alopecia
Conditions
Keywords
Secretome, Minoxidil, Skin, Androgenetic alopecia
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.
Interventions
COMBINATION_PRODUCTCombination of minoxidil and secretome from adipose-derived stem cells
20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA
20 subjects received minoxidil only for the treatment of AGA
OTHERSecretome from adipose-derived stem cells
20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA
Sponsors
Ministry of Education, Culture, Research, and Technology, Republic of Indonesia
PT. Kimia Farma (Persero) Tbk
Dr. dr. Lili Legiawati, SpKK(K)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
This study was a single-blind clinical trial, masking the investigator and outcomes assessor
Intervention model description
Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
Eligibility
Sex/Gender
MALE
Age
18 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of alopecia in physical examination | Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial) | The investigator conduct a scalp examination every 4 weeks until the twelfth week to measure the improvement of alopecia with Hamilton-Norwood scale |
| Macroscopic hair growth documented | Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial) | The investigator conducted documentation of the subject in 7 positions, so that the improvement of alopecia can be seen from various directions |
| Microscopic hair growth evaluated by Trichoscopy | Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial) | Microscopic hair growth was documented using Heine® Delta 20 Plus (Heine, Germany) dermoscopy for qualitative measurement |
| Microscopic hair growth evaluated by Trichoscan | Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial) | The investigator use Fotofinder® medicam 1000 s video-trichoscopy (FotoFinder Systems GmbH, Germany) for quantitative measurements, such as hair rate anagen (%), hair rate telogen (%), hair rate terminal (%), and hair rate vellus (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Week 12 (end of trial) | The patient satisfaction scale using a linear analog scale with a scale of 1-7 (1 = no result, 7 = very satisfactory outcome) and was evaluated at the last treatment session. |
Countries
Indonesia
Outcome results
None listed