Dutasteride 0.3% | GHK-Cu 0.5% | Minoxidil 8%

Route: Topical scalp application.

• Apply the prescribed volume to affected scalp areas once or twice daily as directed by the prescriber.
• Part hair at areas of thinning and apply directly to scalp skin — not to hair shafts.
• Distribute with fingertips; wash hands thoroughly after application.
• Allow to dry completely before styling hair or applying other scalp products.
• Avoid eyes and mucous membranes; rinse immediately with water if contact occurs.

Dosing frequency and volume are determined by the prescribing clinician. General guidance based on pharmacological reference:

• Typically applied once daily (QD) or twice daily (BID) to affected scalp areas.
• Volume per application is prescriber-specified (e.g., 1–2 mL or a defined number of pump actuations).
• Consistent daily application is necessary; benefits from all three components require sustained use (typically assessed at 3–6 months).
• Minoxidil effects: visible results generally emerge at 3–6 months; dutasteride DHT suppression begins within weeks but follicular response takes months.

All dosing decisions are prescriber-directed.

• Dutasteride (0.3%): Competitively inhibits both type 1 and type 2 isoforms of 5α-reductase, reducing local DHT synthesis by up to 98–99%. DHT excess causes hair follicle miniaturization by shortening the anagen phase; its reduction attenuates this process. Topical application limits systemic DHT suppression compared to oral dosing.
• GHK-Cu (0.5%): The GHK tripeptide with coordinated copper(II) binds TrkA and p75NTR neurotrophin receptors and stimulates production of VEGF and HGF in hair follicle cells, promoting angiogenesis and follicular papilla cell proliferation. It activates the Wnt/β-catenin signaling pathway, a key regulator of the hair follicle cycle, and stimulates stem cell activation. GHK-Cu also promotes collagen synthesis and tissue repair in the dermal papilla environment.
• Minoxidil (8%): Opens ATP-sensitive potassium channels (KATP) in vascular smooth muscle and hair follicle cells, causing vasodilation, increased scalp microcirculation, and direct follicular cell stimulation. It prolongs the anagen phase, increases follicle size, and upregulates prostaglandin E2 synthesis, which promotes hair growth signaling.

Clinical Context: This triple-combination topical is compounded for patients with androgenetic alopecia (male or female pattern hair loss) who may benefit from simultaneous DHT suppression (dutasteride), follicular growth factor stimulation (GHK-Cu), and vasodilatory/anagen prolongation (minoxidil). Dutasteride (oral) has demonstrated superiority to finasteride in clinical studies of AGA; topical formulations are used to reduce systemic DHT suppression. Minoxidil is FDA-approved topically for AGA; topical dutasteride and GHK-Cu are off-label compounded components in this formulation.

Monitoring:

• Clinical hair density assessment at 3 and 6 months (standardized photography or trichoscopy).
• Serum DHT (if systemic effects are a concern, particularly in patients with PSA concerns).
• PSA monitoring in men (dutasteride can reduce PSA by 50% even topically in some formulations — account for this in prostate cancer screening).
• Assessment for scalp irritation, contact dermatitis, or systemic minoxidil effects (peripheral edema, tachycardia at high doses).

Contraindications:

• Pregnancy and women of childbearing potential without effective contraception — dutasteride is a Category X teratogen; risk of abnormal male genital development in male fetuses.
• Hypersensitivity to any component (dutasteride, minoxidil, copper compounds, or excipients).
• Pediatric patients: safety not established.

Warnings & Precautions:

• Dutasteride: Even topically, some systemic absorption may occur; sexual side effects (decreased libido, erectile dysfunction, reduced ejaculate volume) are possible though lower risk than oral therapy. PSA reduction of up to 50% may mask prostate cancer — adjust PSA interpretation accordingly.
• Minoxidil: Scalp irritation, contact dermatitis, and hypertrichosis at application sites. Systemic absorption with high-strength formulations may cause fluid retention, tachycardia, and hypotension in susceptible patients.
• GHK-Cu: Limited systemic safety data from topical use at 0.5%; copper toxicity is not expected at standard topical doses but skin hypersensitivity is possible.

Drug Interactions:

• Dutasteride component: May interact with CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) if systemic absorption is significant.
• Minoxidil: Additive hypotension with antihypertensives; caution with guanethidine.

Common Side Effects: Scalp irritation, pruritus, contact dermatitis, initial shedding phase (minoxidil-related, typically transient), and hypertrichosis on face/neck if the product contacts unintended areas. Sexual side effects are less common than with oral dutasteride but should be monitored.

Store at controlled room temperature (20–25°C / 68–77°F) unless the specific formulation vehicle requires refrigeration (consult pharmacy label). Protect from light and heat. Keep container tightly closed. Do not freeze. GHK-Cu peptide integrity may be sensitive to elevated temperature and UV exposure. Store out of reach of children. Use before the beyond-use date assigned by Genesis Compounding.

Why are three different agents combined in this formulation?

Each ingredient targets a distinct mechanism of androgenetic alopecia: dutasteride suppresses DHT (the primary androgen driving follicular miniaturization), minoxidil prolongs the hair growth cycle and improves scalp blood flow, and GHK-Cu stimulates follicular growth factors and cellular signaling pathways. Combining them may provide additive or complementary benefit.

Is dutasteride safe to use topically?

Topical application of dutasteride delivers the drug primarily to scalp tissue, limiting — though not eliminating — systemic absorption compared to oral dosing. This may reduce systemic sexual side effects, though patients should still be monitored for any adverse effects. Women of childbearing potential should not handle this preparation due to teratogenic risk.

What is GHK-Cu, and is it evidence-based?

GHK-Cu is a naturally occurring copper-binding tripeptide found in human plasma. Preclinical evidence supports its role in stimulating VEGF and HGF in hair follicle cells and activating Wnt/β-catenin signaling. While animal and in vitro evidence is encouraging, large-scale human RCT data for hair growth specifically remain limited. Its inclusion is at the prescriber's clinical judgment.

How long before I see results?

Hair follicle cycling means that visible improvement in density typically requires a minimum of 3–6 months of consistent daily use. An initial shedding phase in the first 2–8 weeks (particularly with minoxidil) is normal and does not indicate treatment failure.

Is this an FDA-approved product?

Minoxidil topical solution is FDA-approved for androgenetic alopecia. Topical dutasteride and GHK-Cu in this combined compounded formulation are not FDA-approved; they are prescribed off-label and compounded patient-specifically by Genesis Compounding as a 503A preparation.