Male Pattern BaldnessCS-SAGA-001NCT05970809
Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss
A study testing SAGA-001 (A) and SAGA-001 (B) in people with Male Pattern Baldness and Androgenetic Alopecia, run by StimuSIL at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at helping people with male pattern hair loss. Two different device configurations are being explored as part of this study. Read more about this study
- Who is it for?
- Ages 22 to 55 years, men only
- Conditions the study is for
- Male Pattern Baldness, Androgenetic Alopecia, Hair Loss/Baldness
- What is being tested?
- SAGA-001 (A) and SAGA-001 (B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is willing to sign an informed consent form
- Subject is within the age group of 22-55 years (including both ages)
- Subject is male
- Subject has AGA with a Stage IIa-V Hamilton-Norwood classification
- Subject's skin is within Fitzpatrick Skin Types I-IV
Who cannot join
- Subjects who have used any formulation or application/administration or type of treatment for disorders of the skin or scalp within 180 days prior to screening, including but not limited to the following treatments:
- Anti-inflammatory medications, including topical steroids
- Antifungal
- Skin, nail, hair rejuvenation supplementation, or IV infusions (includes vitamin, minerals, herbals, etc.)
- Hair growth shampoos, conditioners, and topicals
- Topical, dermal or oral minoxidil, finasteride, or dutasteride
Show all 29Show fewer
- Hair growth stimulation treatments, i.e. PRP, stem cells, exosomes, growth factors, microneedling, mesotherapy
- LED or low level laser therapy treatments, ie. laser helmets, laser caps, and laser combs
- Infrared saunas
- Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia
- Subjects with a history of bleeding disorders
- Subjects on anticoagulant medications (aspirin, warfarin, heparin)
- Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g. humira)
- Subjects with an active infection at the local site
- Subjects with keloidal tendencies
- Subjects with chronic dermatological conditions affecting the scalp (e.g. eczema, psoriasis, etc.)
- Subjects with hepatic or renal disease, epilepsy, or any other major medical illness*
- Subjects that have undergone evaluation to rule out other causes of hair loss, because underlying causes (e.g., iron deficiency, lupus, thyroid disease, telogen effluvium, post-pregnancy, polycystic ovary, chemotherapy, etc.) would preclude assessment of performance in an androgenetic alopecia trial
- Subjects who are photosensitive or are using photosensitive drugs or topicals.
- Subjects who are taking anxiolytics medications
- Subjects who have been on hormone inhibitors or on hormone replacement therapy in the last 180 days
- Subjects who are at high risk of seizures
- Subjects who have a malignancy or a history of malignancies affecting the scalp
- Subjects that have undergone hair transplantation, scalp reduction, radiation to the scalp or chemotherapy within their lifetime.
- Subjects with current hair weaves, hair extensions, scalp tattoos, or who use occlusive wigs.
- Subjects who have used semi-permanent hair products (e.g. color, texturizers or relaxers) within 30 days prior to screening.
- Subjects with hair shorter than one-half inch (approximately 1.2 cm).
- Subjects who are unable to make regular follow-up visits.
- Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative sites, or individuals who are directly affiliated with the study at the investigative sites, or individuals directly affiliated with the study sponsor.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Bilkent Şehir Hastanesi Dermatoloji Klini
Ankara
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü Deri ve Zührevi Hastalıklar Ana Bilim Dalı Kocamustafa Paşa
Istanbul
About this study
Official title: A Randomised, Evaluator-Blinded, Two-Arm Study To Evaluate The Safety And Efficacy of a Novel Microneedle and Laser-Based Medical Device For The Treatment of Androgenetic Alopecia in Adult Males
The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at helping people with male pattern hair loss.
Two different device configurations are being explored as part of this study. Device A has novel microneedles, lasers, and additional metal microneedles, while Device B only has novel microneedles and lasers.
Participants will receive 12 treatments with either Device A or Device B over the course of 24 weeks. Treatments will be performed on-site every two weeks.
Read the detailed description
Participants will have the medical tests or procedures described below:
- Subjects will be asked about their previous medical history and current medications.
- Brief physical examinations will be performed, including a visual inspection of the scalp.
- Questions about medical history (including previous and current medication use) will be asked.
- Two types of photos will be taken: 1) "global photos", which are general photos of the subject's scalp, and 2) "macro photos", which are close-up photos of a part of the subject's scalp.
- Questions about treatment-related issues or unpleasantness will be asked.
- Subjects will be asked to rate the improvement they see in their photos.
- Subjects will be asked to rate their satisfaction with the treatment.
Participants will also be asked to record changes in medications, changes in medical treatments, and major life changes (such as major dietary changes, exercise changes, changes in life stressors, etc.) in a diary for the duration of treatment. They should also make note of any suspected side effects or issues they believe are related to the treatment.
- Conditions
- Male Pattern Baldness, Androgenetic Alopecia, Hair Loss/Baldness, Hair Loss, Pattern Baldness
- Being tested
- SAGA-001 (A), SAGA-001 (B)
- Keywords
- lasers, laser therapy, low-level light therapy, Low-Power Laser Therapy, Photobiomodulation Therapy, Low-Level Laser Therapy, Laser Biostimulation, LLLT, microtrauma, physical
- Medical subject headings
- Alopecia, Microtrauma, Physical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGA-001 (A)Device
Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.
SAGA-001 (B)Device
Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.
| Study group | Role | What they receive |
|---|---|---|
| Device A | Experimental | Device configuration A has metal and novel microneedles and lasers. Receives: Device: SAGA-001 (A) |
| Device B | Experimental | Device configuration B has novel microneedles and lasers. Receives: Device: SAGA-001 (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in terminal hair density
Changes in terminal hair density at the 24-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
Measured: 24 weeks
Change in terminal hair density
Changes in terminal hair density at the 16-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
Measured: 16 weeks
Secondary outcomes (2)
Change in hair thickness
Increases and/or decreases in hair diameter at the 16-week time point compared to baseline will be investigated using a paired t-test at a one-sided alpha and a 95% confidence interval for mean change.
Measured: 16 weeks
Change in hair thickness
Increases and/or decreases in hair diameter at the 24-week time point compared to baseline will be investigated using a paired t-test at a one-sided alpha and a 95% confidence interval for mean change.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Aug 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Pattern BaldnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- StimuSIL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ankara City Hospital Bilkent, Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
- Investigators
- Server Serdaroğlu, MD, Principal investigator, İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970809
- Sponsor's protocol ID
- CS-SAGA-001
- Acronym
- CS-SAGA-001
- Status last verified
- May 2025
- First submitted
- 20 Jul 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Evaluator-Blinded, Two-Arm Study To Evaluate The Safety And Efficacy of a Novel Microneedle and Laser-Based Medical Device For The Treatment of Androgenetic Alopecia in Adult Males
- ClinicalTrials.gov ID
- NCT05970809
- Acronym / sponsor ID
- CS-SAGA-001 / CS-SAGA-001
- Conditions
- Male Pattern Baldness, Androgenetic Alopecia, Hair Loss/Baldness, Hair Loss, Pattern Baldness
- Keywords
- lasers, laser therapy, low-level light therapy, Low-Power Laser Therapy, Photobiomodulation Therapy, Low-Level Laser Therapy, Laser Biostimulation, LLLT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- StimuSILIndustry (pharma, biotech, devices)
- Collaborators
- Ankara City Hospital Bilkent, Istanbul University - Cerrahpasa
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at helping people with male pattern hair loss.
Two different device configurations are being explored as part of this study. Device A has novel microneedles, lasers, and additional metal microneedles, while Device B only has novel microneedles and lasers.
Participants will receive 12 treatments with either Device A or Device B over the course of 24 weeks. Treatments will be performed on-site every two weeks.
Detailed description
Participants will have the medical tests or procedures described below:
- Subjects will be asked about their previous medical history and current medications.
- Brief physical examinations will be performed, including a visual inspection of the scalp.
- Questions about medical history (including previous and current medication use) will be asked.
- Two types of photos will be taken: 1) "global photos", which are general photos of the subject's scalp, and 2) "macro photos", which are close-up photos of a part of the subject's scalp.
- Questions about treatment-related issues or unpleasantness will be asked.
- Subjects will be asked to rate the improvement they see in their photos.
- Subjects will be asked to rate their satisfaction with the treatment.
Participants will also be asked to record changes in medications, changes in medical treatments, and major life changes (such as major dietary changes, exercise changes, changes in life stressors, etc.) in a diary for the duration of treatment. They should also make note of any suspected side effects or issues they believe are related to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device A | Experimental | Device: SAGA-001 (A)Device configuration A has metal and novel microneedles and lasers. |
| Device B | Experimental | Device: SAGA-001 (B)Device configuration B has novel microneedles and lasers. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is willing to sign an informed consent form
- Subject is within the age group of 22-55 years (including both ages)
- Subject is male
- Subject has AGA with a Stage IIa-V Hamilton-Norwood classification
- Subject's skin is within Fitzpatrick Skin Types I-IV
Key exclusion criteria (29 listed)
- Subjects who have used any formulation or application/administration or type of treatment for disorders of the skin or scalp within 180 days prior to screening, including but not limited to the following treatments:
- Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia
- Subjects with a history of bleeding disorders
- Subjects on anticoagulant medications (aspirin, warfarin, heparin)
- Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g. humira)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGA-001 (A)Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding. | Device | Device A |
| SAGA-001 (B)Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding. | Device | Device B |
Primary outcome
Change in terminal hair density
Time frame: 24 weeks
Changes in terminal hair density at the 24-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
Change in terminal hair density
Time frame: 16 weeks
Changes in terminal hair density at the 16-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
2 secondary outcomes
Change in hair thickness
Time frame: 16 weeks
Change in hair thickness
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- StimuSIL's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Male Pattern Baldness
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Active, not recruitingPhase 3
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Androgenetic Alopecia, Female Pattern Baldness
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Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
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A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Server Serdaroğlu, MD principal investigator
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAGA-001 (A) and SAGA-001 (B) in people with Male Pattern Baldness and Androgenetic Alopecia, run by StimuSIL at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in terminal hair density (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.