Med Dallas

Hair Care

Hair Restore D Scalp Solution

Hair Restore D Scalp Solution, featuring a 1% concentration of topical dutasteride, is designed for the treatment of male pattern baldness, also known as androgenetic alopecia. This topical solution harnesses the power of dutasteride, a 5-alpha-reductase inhibitor, to target and reduce dihydrotestosterone (DHT) levels directly at the site of hair loss. By inhibiting the enzyme responsible for converting testosterone into DHT, Hair Restore D helps mitigate hair follicle miniaturization and supports hair regrowth. Currently undergoing Phase 2 clinical trials in the US, this solution is positioned as a potential breakthrough in managing hair loss, with results anticipated by April 2024.

About Hair Restore D Scalp Solution

Indications

Primary Use: Dutasteride is FDA-approved for the treatment of symptomatic benign prostatic hyperplasia (BPH), either alone or in combination with tamsulosin. Off-Label Use: Dutasteride is used off-label for treating male-pattern baldness (androgenetic alopecia).

Guidelines

According to the American Urological Association (AUA), 5-alpha-reductase inhibitors (5-ARIs) like dutasteride can be effective in preventing the progression of lower urinary tract symptoms (LUTS) secondary to BPH and reducing the risk of urinary retention and prostate-related surgery. Guideline Recommendations: 5-ARIs should only be used if prostatic enlargement is present, as their use in the absence of enlargement is not recommended

Safety and Efficacy

Prostate Cancer Risk: Research from two large randomized controlled trials indicates that while 5-ARIs may reduce the risk of low-grade prostate cancer, they may increase the risk of high-grade prostate cancer. Therefore, the benefits of using 5-ARIs must be carefully weighed against the potential risks. Pre-Treatment Assessment: Patients should be evaluated to rule out other urological diseases before starting dutasteride and monitored periodically during treatment.

Precautions

Pregnancy Risk: 5-ARIs, including dutasteride, can cause abnormalities in the external genitalia of the male fetus. Pregnant women or women trying to conceive should avoid handling dutasteride. Any contact with a leaking capsule should be followed by immediate washing of the affected area with soap and water.

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Effective Targeting of Hair Loss

Hair Restore D Scalp Solution works by reducing the levels of DHT, a hormone linked to hair follicle shrinkage and male pattern baldness. By preventing the conversion of testosterone into DHT, the solution directly addresses the underlying cause of hair loss. This targeted approach aims to reverse follicle miniaturization and promote healthier hair regrowth.

Enhanced Prostate Health Benefits

While primarily used for hair restoration, dutasteride is also known for its benefits in treating benign prostatic hyperplasia (BPH). By reducing DHT levels, Hair Restore D may help alleviate prostate enlargement symptoms, such as urinary obstruction.

Long-Term Efficacy and Safety

Dutasteride's long half-life of approximately 5 weeks ensures sustained therapeutic effects, making it a reliable choice for long-term management of both BPH and hair loss. The prolonged duration helps maintain consistent DHT suppression, contributing to ongoing symptom relief and improved outcomes.

Product Overview

5/5

Dosage Strengths

Nourishes the Scalp
1
Reduces Hair Thinning
2
Revitalizes Damaged Hair
3

More Details About Product

Androgen Conversion
  • Primary Action: Dutasteride is a 5-alpha-reductase inhibitor that prevents the conversion of testosterone into 5-alpha-dihydrotestosterone (DHT).
  • Enzyme Isoforms:
    • Type I Isoenzyme: Active mainly in the skin and liver.
    • Type II Isoenzyme: Predominantly active in reproductive tissues such as the prostate, seminal vesicles, and epididymides, and is responsible for approximately two-thirds of circulating DHT.
Effects on Prostate Tissue
  • Benign Prostatic Hyperplasia (BPH): By reducing circulating DHT, dutasteride decreases prostate hypertrophy and improves urine flow.
Effects on Hair Loss
  • Male Pattern Baldness: The balding scalp typically has miniaturized hair follicles and elevated levels of DHT compared to areas with normal hair growth. Dutasteride reduces DHT concentrations in both the scalp and serum, addressing a primary factor in androgenetic alopecia in genetically predisposed individuals.
Pharmacodynamic Effects
  • Total Serum PSA: Dutasteride reduces total serum prostate-specific antigen (PSA) levels.
  • Total Testosterone: There is an increase in total testosterone levels.
  • Thyroid-Stimulating Hormone (TSH): An increase in TSH levels is observed.
  • DHT Levels: A decrease in total serum DHT is noted, with the reduction being dose-dependent and observable within 1 to 2 weeks of treatment.
  • Unchanged Hormone Levels: Dutasteride does not affect circulating levels of sex hormone-binding globulin (SHBG), estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroxine (free T4), or dehydroepiandrosterone (DHEA) in healthy volunteers.
  • Hypothalamic-Pituitary-Testicular Axis: Dutasteride does not impact this axis.
Additional Notes
  • Androgen Receptors: Dutasteride does not bind to androgen receptors in humans, which is significant for its selective action on enzyme inhibition rather than receptor interaction.
Contraindications
  • Hypersensitivity: Dutasteride is contraindicated in patients with a known hypersensitivity to the drug or any of its components. Cross-sensitivity with other 5-alpha-reductase inhibitors is possible.
  • Pregnancy: Dutasteride is contraindicated in females of childbearing potential and during pregnancy due to its potential to cause abnormalities in the external genitalia of the male fetus. Women who are pregnant or trying to conceive should avoid handling dutasteride capsules. If skin contact with a leaking capsule occurs, wash the affected area immediately with soap and water.
  • Breastfeeding: Dutasteride is not recommended for use during breastfeeding, as it is not known whether the drug is excreted in human milk and its effects on infants are not determined.
  • Neonates, Infants, Children, and Adolescents: Safety and effectiveness in these age groups have not been established.
Precautions
  • Renal Impairment: The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, less than 0.1% of a steady-state dose of 0.5 mg is recovered in urine, so no dosage adjustment is expected for patients with renal impairment.
  • Hepatic Disease: Use with caution in patients with hepatic disease. Dutasteride is extensively metabolized by the liver and has a long half-life of about 5 weeks. The effect of potent hepatic CYP3A4 isoenzyme inhibitors on its metabolism has not been studied.
  • Elderly Patients: No significant differences in safety or effectiveness between elderly (>65 years) and younger adult patients have been observed.
  • Prostate-Specific Antigen (PSA): Dutasteride reduces PSA levels, which may affect the interpretation of PSA tests. Establish a new baseline PSA concentration after 3-6 months of treatment. For men on dutasteride for 6 months or more, double the PSA value for comparison with normal values. Increased PSA levels during treatment may indicate potential prostate cancer.
  • Blood Donation: Males treated with dutasteride should avoid blood donation until at least 6 months after their last dose to prevent exposure of dutasteride to pregnant women through blood transfusion.
  • Semen Characteristics: Dutasteride may affect spermatogenesis, semen volume, and sperm motility. Clinical significance for fertility is not well understood. Evaluate semen parameters in men with infertility concerns.
Special Considerations
  • Cardiac Effects: Increased incidences of heart failure have been observed in some studies, though a causal relationship with dutasteride has not been established.
  • Urological Assessment: Prior to starting treatment, and periodically thereafter, assess patients to rule out other urological conditions, including prostate cancer. Patients with significant residual urinary volume or diminished urinary flow should be monitored closely.
Adverse Reactions / Side Effects Reported Side Effects from Minimal Studies:
  • Headaches
  • Itchiness
  • Pain
Side Effects Noted in Studies Including Microneedling:
  • Dryness and Flakiness
  • Scaling
  • Changes in Hair Texture or Color
  • Skin Sensitivity
  • Greater Sensitivity to the Sun
Note: It is important to distinguish between side effects that might be attributable to the topical application of dutasteride alone and those that may result from the combination of topical dutasteride with microneedling. Further research is needed to clarify which specific aspect of the therapy (dutasteride alone or in combination with microneedling) contributes to these side effects.
Pregnancy & Breastfeeding Pregnancy:
  • Contraindication: Dutasteride is contraindicated for use in females of childbearing potential. It is specifically contraindicated during pregnancy due to its potential to cause abnormalities in the external genitalia of the male fetus.
  • Handling Precautions: Pregnant women or those trying to conceive should avoid handling dutasteride capsules, as the drug can be absorbed through the skin, leading to potential fetal exposure. If contact with a leaking capsule occurs, the affected area should be washed with soap and water immediately.
Breastfeeding:
  • Contraindication: Dutasteride is not indicated for use in women of childbearing potential and is contraindicated during breastfeeding. It is not known whether dutasteride is excreted in human milk, so the effects on infants cannot be determined.
Additional Information:
  • Semen Exposure: Dutasteride is secreted into male semen, but the amount available for vaginal absorption is estimated to be significantly lower than concentrations that cause abnormalities in the genitalia of male offspring in animal studies. Furthermore, the high level of protein binding in human semen (more than 96%) may further reduce vaginal absorption of the drug.
Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.