XVIE to Treat Androgenetic Alopecia (AGA)

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Androgenetic Alopecia

In brief

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.

Key facts

Study ID

NCT07482423

Run by

Restore Biologics Holdings, Inc. dba Xtressé

People needed

30

Starts

2026-05-01

Expected to finish

2027-05-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Advanced Dermatology and Cosmetic Surgery — Orlando, Florida, United States
• Kindred Hair & Skin Center — Marriottsville, Maryland, United States

Full record on ClinicalTrials.gov

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