CS-SAGA-001: Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss

Sponsor

StimuSIL (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05970809

Collaborator

Ankara City Hospital Bilkent (Other), Istanbul University - Cerrahpasa (IUC) (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Male Pattern Baldness Androgenetic Alopecia Hair Loss/Baldness Hair Loss Pattern Baldness	Device: SAGA-001 (A) Device: SAGA-001 (B)	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Participants will be randomly allocated at a 1:1 ratio to receive treatment with Device type A or B.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device A Device configuration A has metal and novel microneedles and lasers.	Device: SAGA-001 (A) Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.
Experimental: Device B Device configuration B has novel microneedles and lasers.	Device: SAGA-001 (B) Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.

Arm

Intervention/Treatment

Experimental: Device A

Device configuration A has metal and novel microneedles and lasers.

Device: SAGA-001 (A)

Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.

Experimental: Device B

Device configuration B has novel microneedles and lasers.

Device: SAGA-001 (B)

Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.

Outcome Measures

Primary Outcome Measures

Change in terminal hair density [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 [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.

Secondary Outcome Measures

Change in hair thickness [16 weeks]
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.
Change in hair thickness [24 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Bilkent Şehir Hastanesi Dermatoloji Klini	Ankara		Turkey
2	İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü Deri ve Zührevi Hastalıklar Ana Bilim Dalı Kocamustafa Paşa	Istanbul		Turkey