Androgenetic AlopeciaPhase 1/2NCT07482423
XVIE to Treat Androgenetic Alopecia (AGA)
A Phase 1/2 study testing Decellularized allogeneic human amniotic fluid and Sodium chloride 0.9% injectable solution in people with Androgenetic Alopecia, run by Restore Biologics Holdings, Inc. dba Xtressé at 2 sites in United States.
Trial summary
This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss). XVIE contains growth factors and extracellular vesicles that may stimulate hair follicle activity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Decellularized allogeneic human amniotic fluid and Sodium chloride 0.9% injectable solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 1 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 70 years (inclusive) at the time of informed consent
- Able to understand and voluntarily provide written informed consent
- Willing and able to comply with study procedures, including all scheduled visits and assessments
- In good general health as determined by the Investigator based on medical history and screening assessments
- Clinical diagnosis of androgenetic alopecia (AGA) with documented hair loss for at least 6 months prior to screening
- Stable pattern of hair loss (no rapid progression) for at least 6 months prior to screening
Show all 13Show fewer
- Male subjects: Norwood-Hamilton Classification Stage III, IIIa, IIIv, IV, or IVa
- Female subjects: Ludwig Classification Stage I or II
- Normal thyroid function (TSH within normal limits) at screening, or stable on thyroid replacement therapy for at least 6 months
- Ferritin level within normal limits at screening, or documented adequate iron stores
- No clinically significant abnormalities on CBC with differential or comprehensive metabolic panel (CMP) at screening outside protocol-defined eligibility thresholds
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and agree to use an effective method of contraception throughout the study and for 30 days after the last treatment
- Female subjects who are postmenopausal (no menses for at least 12 months) or surgically sterile are not required to use contraception
Who cannot join
- Use of topical or oral minoxidil within 3 months prior to screening
- Use of oral finasteride or dutasteride within 6 months prior to screening
- Use of topical finasteride within 3 months prior to screening
- Platelet-rich plasma (PRP), exosome, or other regenerative scalp injections within 6 months prior to screening
- Hair transplant surgery within 12 months prior to screening
- Low-level laser therapy (LLLT) or other light-based hair treatments within 3 months prior to screening
Show all 33Show fewer
- Scalp microneedling within 3 months prior to screening
- Use of drugs with anti-androgenic properties (e.g., spironolactone, cyproterone acetate, flutamide) within 6 months prior to screening
- Systemic corticosteroids within 2 weeks prior to screening, or corticosteroid scalp injections within 1 month prior to screening
- Chronic daily NSAID use (defined as daily use for 14 or more consecutive days), other than low-dose aspirin (81 mg/day or less) for cardiovascular prophylaxis
- Diagnosis or history of alopecia areata, cicatricial (scarring) alopecia, telogen effluvium, traction alopecia, or other non-AGA hair loss conditions
- Norwood-Hamilton Stage V, VI, or VII (male subjects); Ludwig Stage III (female subjects)
- Active or history of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
- Known or suspected autoimmune disease (e.g., lupus, rheumatoid arthritis, psoriasis with scalp involvement)
- Known or newly identified immunodeficiency or immunocompromised state, including HIV infection identified at screening
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) at screening
- Platelet count less than 100,000/µL, bleeding disorder, or hemoglobin less than 10 g/dL at screening
- Current use of anticoagulant therapy (e.g., warfarin, heparin, direct oral anticoagulants), P2Y12 receptor inhibitors (e.g., clopidogrel, prasugrel, ticagrelor), phosphodiesterase inhibitor antiplatelet agents (e.g., cilostazol, dipyridamole), or dual antiplatelet therapy
- Uncontrolled thyroid disease or thyroid dysfunction not adequately managed on stable therapy
- Uncontrolled diabetes (HbA1c greater than 9%) or other significant metabolic disorder
- Active scalp infection, inflammation, or dermatological condition in the treatment area
- Open wounds, abrasions, or abnormalities on the scalp in the intended treatment area
- History of keloid formation or propensity for keloids
- Hair weaving or use of hair pieces that cannot be removed for study assessments
- Known hypersensitivity or allergy to any component of XVIE or human-derived biological products
- Known allergy to lidocaine or other local anesthetics
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
- Positive urine pregnancy test at screening or Day 0
- Participation in another interventional clinical trial within 30 days prior to screening or concurrent participation in another clinical study
- History of drug or alcohol abuse within 12 months prior to screening
- Use of systemic immunosuppressive therapy within 5 half-lives or 30 days prior to screening, whichever is longer, including biologic agents, conventional DMARDs, JAK inhibitors, and calcineurin inhibitors
- Use of topical JAK inhibitors applied to the scalp within 30 days prior to screening
- Any condition that, in the Investigator's judgment, would make the subject unsuitable for study participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa Rayner contact
United States2 sites
Kindred Hair & Skin Center
Marriottsville, Maryland, 21104
Chesahna Kindred, MD, (443) 424-7754, info@kindredhairandskin.com
Advanced Dermatology and Cosmetic Surgery
Orlando, Florida, 32827
Matt Leavitt, DO, (407) 745-1966, info@xtresse.com
About this study
Official title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Potential Efficacy of XVIE Injected Intradermally in Patients With Androgenetic Alopecia
This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss). XVIE contains growth factors and extracellular vesicles that may stimulate hair follicle activity. Thirty participants will be randomly assigned to receive either XVIE or a saline placebo injected into the scalp in two treatment sessions, 90 days apart. Neither participants nor study staff will know which treatment is being given. Participants will be followed for 6 months. The main goal is to evaluate safety. A secondary goal is to assess whether hair count, density, or coverage improves.
Read the detailed description
This Phase I/II randomized, double-blind, placebo-controlled trial evaluates the safety and preliminary efficacy of XVIE (decellularized allogeneic human amniotic fluid) administered via intradermal scalp injection in adults with androgenetic alopecia (AGA).
XVIE is manufactured by Nova Vita Laboratories, LLC under cGMP-aligned conditions. It contains naturally occurring soluble proteins, extracellular vesicles (nanoparticles 50-200 nm), and hyaluronic acid derived from full-term human amniotic fluid. Cellular components are removed by centrifugation and sterile filtration. Each lot is released against a 7-parameter specification panel including nanoparticle concentration, size, total protein, sterility, endotoxin, mycoplasma, and appearance.
Thirty adults (ages 18-70) with AGA will be randomized 1:1 to XVIE or placebo (0.9% saline). Both are supplied in identical 2.0 mL vials. Treatment is administered intradermally across 20 scalp injection sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle) at Day 0 and Day 90. Final assessment occurs at Day 180 with no treatment administered.
Safety assessments include incidence, severity, and relatedness of treatment-emergent adverse events (TE-AEs) and serious adverse events (TE-SAEs), graded per CTCAE v5.0. Adverse events of special interest include scalp-specific events such as new-onset alopecia in previously unaffected areas, a decrease of 15% or greater in Total Area Hair Count within the injection zone, and scarring alopecia not consistent with natural AGA progression.
Efficacy assessments include Total Area Hair Count and hair density measured by Canfield HairMetrix imaging, global scalp coverage by SoCAI Global HairMap, Investigator and Subject Global Assessments (7-point scale), and quality of life via the Dermatology Life Quality Index (DLQI).
Male subjects must be Norwood-Hamilton Stage III-IVa; female subjects must be Ludwig Stage I-II. The study is conducted at two U.S. clinical sites: Advanced Dermatology and Cosmetic Surgery in Orlando, FL and Kindred Hair \& Skin Center in Marriottsville, MD.
An independent Data Safety Monitoring Board (DSMB) will oversee participant safety throughout the trial. Enrollment will not begin until the DSMB is fully constituted and the DSMB Charter has been executed.
- Conditions
- Androgenetic Alopecia
- Being tested
- Decellularized allogeneic human amniotic fluid, Sodium chloride 0.9% injectable solution
- Keywords
- Androgenetic alopecia, Pattern hair loss, Extracellular vesicles, Human amniotic fluid, Intradermal injection, Hair regrowth, Decellularized biological product, XVIE
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decellularized allogeneic human amniotic fluidBiological
Decellularized allogeneic human amniotic fluid (hAF) processed by centrifugation and sterile filtration to remove cellular components while preserving bioactive growth factors, extracellular vesicles, and hyaluronic acid. Supplied as a ready-to-use 2.0 mL frozen liquid in a borosilicate glass vial. Administered undiluted via intradermal scalp injection across 20 sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle). Manufactured by Nova Vita Laboratories, LLC.
Sodium chloride 0.9% injectable solutionDrug
Sterile 0.9% sodium chloride for injection supplied in 2.0 mL borosilicate glass vials identical in appearance, packaging, and labeling to the active product. Administered via intradermal scalp injection across 20 sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle) at Day 0 and Day 90.
| Study group | Role | What they receive |
|---|---|---|
| XVIE | Experimental | Participants receive 2.0 mL of XVIE (decellularized allogeneic human amniotic fluid) administered via intradermal scalp injection at Day 0 and Day 90. Product is delivered across 20 injection sites (0.1 mL per site) at 4-5 mm depth using a 30-gauge needle. Receives: Biological: Decellularized allogeneic human amniotic fluid |
| Placebo | Placebo comparator | Participants receive 2.0 mL of sterile 0.9% sodium chloride for injection (normal saline) administered via intradermal scalp injection at Day 0 and Day 90. Delivered across 20 injection sites (0.1 mL per site) at 4-5 mm depth using a 30-gauge needle. Placebo is supplied in identical vials with identical packaging and labeling to the active product. Receives: Drug: Sodium chloride 0.9% injectable solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TE-AEs) and treatment-emergent serious adverse events (TE-SAEs) as assessed by CTCAE v5.0
Incidence, severity, and relatedness of all TE-AEs and TE-SAEs graded per CTCAE v5.0, including protocol-defined adverse events of special interest: new-onset alopecia in previously unaffected scalp areas, decrease of 15% or greater in Total Area Hair Count (TAHC) within the injection zone relative to baseline, and Investigator-determined scarring alopecia not consistent with natural AGA progression.
Measured: Baseline through Day 180
Secondary outcomes (7)
Change in Total Area Hair Count (TAHC) as measured by Canfield HairMetrix Automated Imaging System
Change from baseline in total hair count within a defined target area (approximately 1.9 cm²) measured by Canfield HairMetrix automated imaging. Target area marked with scalp tattoo dots for precise repositioning at each visit.
Measured: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in hair density (hairs/cm²) as measured by Canfield HairMetrix Automated Imaging System
Change from baseline in hair density (hairs/cm²) within the defined target area measured by Canfield HairMetrix imaging.
Measured: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in mean hair shaft diameter (mm) as measured by Canfield HairMetrix Automated Imaging System
Change from baseline in mean hair shaft diameter/caliber (mm) within the defined target area measured by Canfield HairMetrix imaging.
Measured: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in global scalp coverage percentage as measured by SoCAI Global HairMap Imaging Platform
Change from baseline in scalp coverage percentage and continuous density score assessed by SoCAI Global HairMap AI-driven imaging platform with heat map visualization.
Measured: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Proportion of participants with improved hair growth response as assessed by Investigator Global Assessment (IGA) 7-point scale
Investigator-rated hair growth response compared to baseline using the Investigator Global Assessment 7-point scale. Scores range from -3 (greatly decreased) to +3 (greatly increased), where higher scores indicate greater hair growth improvement. A score of 0 indicates no change. Responder rate defined as proportion of participants achieving a score of +1 or greater.
Measured: Month 3 (Day 90), Month 6 (Day 180)
Proportion of participants with improved hair growth response as assessed by Subject Global Assessment (SGA) 7-point scale
Subject-rated perceived hair growth response compared to baseline using the Subject Global Assessment 7-point scale. Scores range from -3 (greatly decreased) to +3 (greatly increased), where higher scores indicate greater perceived hair growth improvement. A score of 0 indicates no change. Responder rate defined as proportion of participants achieving a score of +1 or greater.
Measured: Month 3 (Day 90), Month 6 (Day 180)
Change in subject-reported quality of life from baseline as assessed by Dermatology Life Quality Index (DLQI) questionnaire
Change from baseline in subject-reported quality of life assessed by the validated 10-item Dermatology Life Quality Index questionnaire measuring the impact of skin conditions on daily functioning. Scores range from 0 to 30, where higher scores indicate greater impairment in quality of life. A score of 0 indicates no impairment.
Measured: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms: active treatment (XVIE) and placebo control (sterile saline), administered identically via intradermal scalp injection at Day 0 and Day 90.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restore Biologics Holdings, Inc. dba Xtressé
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482423
- Sponsor's protocol ID
- RBH-2026-001
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radjenovic PM, Hardwick LJ. Time-resolved SERS study of the oxygen reduction reaction in ionic liquid electrolytes for non-aqueous lithium-oxygen cells. Faraday Discuss. 2018 Jan 1;206:379-392. doi: 10.1039/c7fd00170c. Epub 2017 Sep 29.
PubMed 28960000Honda M, Ichibayashi R, Yokomuro H, Yoshihara K, Masuda H, Haga D, Seiki Y, Kudoh C, Kishi T. Early Cerebral Circulation Disturbance in Patients Suffering from Severe Traumatic Brain Injury (TBI): A Xenon CT and Perfusion CT Study. Neurol Med Chir (Tokyo). 2016 Aug 15;56(8):501-9. doi: 10.2176/nmc.oa.2015-0341. Epub 2016 Jun 29.
PubMed 27356957Zhang Q, Wang H, Shi Y, Li W. White matter biomarker for predicting de novo Parkinson's disease using tract-based spatial statistics: a machine learning-based model. Quant Imaging Med Surg. 2024 Apr 3;14(4):3086-3106. doi: 10.21037/qims-23-1478. Epub 2024 Mar 28.
PubMed 38617147Cappelli G, Giovannini D, Vilardo L, Basso A, Iannetti I, Massa M, Ruberto G, Muir R, Pastore C, D'Agnano I, Mariani F. Cinnamomum zeylanicum Blume Essential Oil Inhibits Metastatic Melanoma Cell Proliferation by Triggering an Incomplete Tumour Cell Stress Response. Int J Mol Sci. 2023 Mar 16;24(6):5698. doi: 10.3390/ijms24065698.
PubMed 36982774Mu J, Zhang Z, Wu L, Fu J, Chen B, Yan Z, Li B, Zhou Z, Wang W, Zhao L, Dong J, Kuang Y, Sun X, He L, Wang L, Sang Q. The identification of novel mutations in PLCZ1 responsible for human fertilization failure and a therapeutic intervention by artificial oocyte activation. Mol Hum Reprod. 2020 Feb 29;26(2):80-87. doi: 10.1093/molehr/gaaa003.
PubMed 31953539Ahmad Nizaruddin M, Omar MS, Mhd-Ali A, Makmor-Bakry M. A qualitative study exploring issues related to medication management in residential aged care facilities. Patient Prefer Adherence. 2017 Nov 1;11:1869-1877. doi: 10.2147/PPA.S144513. eCollection 2017.
PubMed 29138540Harmatz PR, Lampe C, Parini R, Sharma R, Teles EL, Johnson J, Sivam D, Sisic Z. Enzyme replacement therapy outcomes across the disease spectrum: Findings from the mucopolysaccharidosis VI Clinical Surveillance Program. J Inherit Metab Dis. 2019 May;42(3):519-526. doi: 10.1002/jimd.12079. Epub 2019 Apr 8.
PubMed 30834539
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Potential Efficacy of XVIE Injected Intradermally in Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07482423
- Acronym / sponsor ID
- RBH-2026-001
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic alopecia, Pattern hair loss, Extracellular vesicles, Human amniotic fluid, Intradermal injection, Hair regrowth, Decellularized biological product, XVIE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Restore Biologics Holdings, Inc. dba XtresséIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 19 Mar 2026 (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.
This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss). XVIE contains growth factors and extracellular vesicles that may stimulate hair follicle activity. Thirty participants will be randomly assigned to receive either XVIE or a saline placebo injected into the scalp in two treatment sessions, 90 days apart. Neither participants nor study staff will know which treatment is being given. Participants will be followed for 6 months. The main goal is to evaluate safety. A secondary goal is to assess whether hair count, density, or coverage improves.
Detailed description
This Phase I/II randomized, double-blind, placebo-controlled trial evaluates the safety and preliminary efficacy of XVIE (decellularized allogeneic human amniotic fluid) administered via intradermal scalp injection in adults with androgenetic alopecia (AGA).
XVIE is manufactured by Nova Vita Laboratories, LLC under cGMP-aligned conditions. It contains naturally occurring soluble proteins, extracellular vesicles (nanoparticles 50-200 nm), and hyaluronic acid derived from full-term human amniotic fluid. Cellular components are removed by centrifugation and sterile filtration. Each lot is released against a 7-parameter specification panel including nanoparticle concentration, size, total protein, sterility, endotoxin, mycoplasma, and appearance.
Thirty adults (ages 18-70) with AGA will be randomized 1:1 to XVIE or placebo (0.9% saline). Both are supplied in identical 2.0 mL vials. Treatment is administered intradermally across 20 scalp injection sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle) at Day 0 and Day 90. Final assessment occurs at Day 180 with no treatment administered.
Safety assessments include incidence, severity, and relatedness of treatment-emergent adverse events (TE-AEs) and serious adverse events (TE-SAEs), graded per CTCAE v5.0. Adverse events of special interest include scalp-specific events such as new-onset alopecia in previously unaffected areas, a decrease of 15% or greater in Total Area Hair Count within the injection zone, and scarring alopecia not consistent with natural AGA progression.
Efficacy assessments include Total Area Hair Count and hair density measured by Canfield HairMetrix imaging, global scalp coverage by SoCAI Global HairMap, Investigator and Subject Global Assessments (7-point scale), and quality of life via the Dermatology Life Quality Index (DLQI).
Male subjects must be Norwood-Hamilton Stage III-IVa; female subjects must be Ludwig Stage I-II. The study is conducted at two U.S. clinical sites: Advanced Dermatology and Cosmetic Surgery in Orlando, FL and Kindred Hair \& Skin Center in Marriottsville, MD.
An independent Data Safety Monitoring Board (DSMB) will oversee participant safety throughout the trial. Enrollment will not begin until the DSMB is fully constituted and the DSMB Charter has been executed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms: active treatment (XVIE) and placebo control (sterile saline), administered identically via intradermal scalp injection at Day 0 and Day 90.
| Arm | Type | Receives |
|---|---|---|
| XVIE | Experimental | Biological: Decellularized allogeneic human amniotic fluidParticipants receive 2.0 mL of XVIE (decellularized allogeneic human amniotic fluid) administered via intradermal scalp injection at Day 0 and Day 90. Product is delivered across 20 injection sites (0.1 mL per site) at 4-5 mm depth using a 30-gauge needle. |
| Placebo | Placebo comparator | Drug: Sodium chloride 0.9% injectable solutionParticipants receive 2.0 mL of sterile 0.9% sodium chloride for injection (normal saline) administered via intradermal scalp injection at Day 0 and Day 90. Delivered across 20 injection sites (0.1 mL per site) at 4-5 mm depth using a 30-gauge needle. Placebo is supplied in identical vials with identical packaging and labeling to the active product. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, aged 18 to 70 years (inclusive) at the time of informed consent
- Able to understand and voluntarily provide written informed consent
- Willing and able to comply with study procedures, including all scheduled visits and assessments
- In good general health as determined by the Investigator based on medical history and screening assessments
- Clinical diagnosis of androgenetic alopecia (AGA) with documented hair loss for at least 6 months prior to screening
Key exclusion criteria (33 listed)
- Use of topical or oral minoxidil within 3 months prior to screening
- Use of oral finasteride or dutasteride within 6 months prior to screening
- Use of topical finasteride within 3 months prior to screening
- Platelet-rich plasma (PRP), exosome, or other regenerative scalp injections within 6 months prior to screening
- Hair transplant surgery within 12 months prior to screening
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 |
|---|---|---|
| Decellularized allogeneic human amniotic fluidDecellularized allogeneic human amniotic fluid (hAF) processed by centrifugation and sterile filtration to remove cellular components while preserving bioactive growth factors, extracellular vesicles, and hyaluronic acid. Supplied as a ready-to-use 2.0 mL frozen liquid in a borosilicate glass vial. Administered undiluted via intradermal scalp injection across 20 sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle). Manufactured by Nova Vita Laboratories, LLC. | Biological | XVIE |
| Sodium chloride 0.9% injectable solutionSterile 0.9% sodium chloride for injection supplied in 2.0 mL borosilicate glass vials identical in appearance, packaging, and labeling to the active product. Administered via intradermal scalp injection across 20 sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle) at Day 0 and Day 90. | Drug | Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events (TE-AEs) and treatment-emergent serious adverse events (TE-SAEs) as assessed by CTCAE v5.0
Time frame: Baseline through Day 180
Incidence, severity, and relatedness of all TE-AEs and TE-SAEs graded per CTCAE v5.0, including protocol-defined adverse events of special interest: new-onset alopecia in previously unaffected scalp areas, decrease of 15% or greater in Total Area Hair Count (TAHC) within the injection zone relative to baseline, and Investigator-determined scarring alopecia not consistent with natural AGA progression.
7 secondary outcomes
Change in Total Area Hair Count (TAHC) as measured by Canfield HairMetrix Automated Imaging System
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in hair density (hairs/cm²) as measured by Canfield HairMetrix Automated Imaging System
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in mean hair shaft diameter (mm) as measured by Canfield HairMetrix Automated Imaging System
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in global scalp coverage percentage as measured by SoCAI Global HairMap Imaging Platform
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Proportion of participants with improved hair growth response as assessed by Investigator Global Assessment (IGA) 7-point scale
Time frame: Month 3 (Day 90), Month 6 (Day 180)
Proportion of participants with improved hair growth response as assessed by Subject Global Assessment (SGA) 7-point scale
Time frame: Month 3 (Day 90), Month 6 (Day 180)
Change in subject-reported quality of life from baseline as assessed by Dermatology Life Quality Index (DLQI) questionnaire
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 28960000Radjenovic PM, Hardwick LJ. Time-resolved SERS study of the oxygen reduction reaction in ionic liquid electrolytes for non-aqueous lithium-oxygen cells. Faraday Discuss. 2018 Jan 1;206:379-392. doi: 10.1039/c7fd00170c. Epub 2017 Sep 29.
- Background: PubMed 27356957Honda M, Ichibayashi R, Yokomuro H, Yoshihara K, Masuda H, Haga D, Seiki Y, Kudoh C, Kishi T. Early Cerebral Circulation Disturbance in Patients Suffering from Severe Traumatic Brain Injury (TBI): A Xenon CT and Perfusion CT Study. Neurol Med Chir (Tokyo). 2016 Aug 15;56(8):501-9. doi: 10.2176/nmc.oa.2015-0341. Epub 2016 Jun 29.
- Background: PubMed 38617147Zhang Q, Wang H, Shi Y, Li W. White matter biomarker for predicting de novo Parkinson's disease using tract-based spatial statistics: a machine learning-based model. Quant Imaging Med Surg. 2024 Apr 3;14(4):3086-3106. doi: 10.21037/qims-23-1478. Epub 2024 Mar 28.
- Background: PubMed 36982774Cappelli G, Giovannini D, Vilardo L, Basso A, Iannetti I, Massa M, Ruberto G, Muir R, Pastore C, D'Agnano I, Mariani F. Cinnamomum zeylanicum Blume Essential Oil Inhibits Metastatic Melanoma Cell Proliferation by Triggering an Incomplete Tumour Cell Stress Response. Int J Mol Sci. 2023 Mar 16;24(6):5698. doi: 10.3390/ijms24065698.
- Background: PubMed 31953539Mu J, Zhang Z, Wu L, Fu J, Chen B, Yan Z, Li B, Zhou Z, Wang W, Zhao L, Dong J, Kuang Y, Sun X, He L, Wang L, Sang Q. The identification of novel mutations in PLCZ1 responsible for human fertilization failure and a therapeutic intervention by artificial oocyte activation. Mol Hum Reprod. 2020 Feb 29;26(2):80-87. doi: 10.1093/molehr/gaaa003.
- Background: PubMed 29138540Ahmad Nizaruddin M, Omar MS, Mhd-Ali A, Makmor-Bakry M. A qualitative study exploring issues related to medication management in residential aged care facilities. Patient Prefer Adherence. 2017 Nov 1;11:1869-1877. doi: 10.2147/PPA.S144513. eCollection 2017.
- Background: PubMed 30834539Harmatz PR, Lampe C, Parini R, Sharma R, Teles EL, Johnson J, Sivam D, Sisic Z. Enzyme replacement therapy outcomes across the disease spectrum: Findings from the mucopolysaccharidosis VI Clinical Surveillance Program. J Inherit Metab Dis. 2019 May;42(3):519-526. doi: 10.1002/jimd.12079. Epub 2019 Apr 8.
- Individual participant dataSharing planned: No
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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.
Melissa Rayner contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Decellularized allogeneic human amniotic fluid and Sodium chloride 0.9% injectable solution in people with Androgenetic Alopecia, run by Restore Biologics Holdings, Inc. dba Xtressé at 2 sites in United States.
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 13 inclusion and 33 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trillitye Paullin, PhD (855-284-8266, trill@xtresse.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TE-AEs) and treatment-emergent serious adverse events (TE-SAEs) as assessed by CTCAE v5.0 (time frame: Baseline through Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07482423, which also lists 7 linked publications.
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 12 Aug 2026.