V-Care

Approved Indications:

Dermatologic Uses (Topical):

• Dry and Scaly Skin Conditions (Xerosis):
  • For the treatment of moderate to severe dry skin by increasing skin hydration and promoting exfoliation.
• Ichthyosis Vulgaris and Other Hyperkeratotic Disorders:
  • Used to improve skin texture and reduce scaling.
• Keratosis Pilaris:
  • Helps reduce follicular plugging and smoothen rough skin.
• Calluses and Corns:
  • Aids in softening thickened skin and enhancing removal.

Gynecologic Use (Vaginal):

• Bacterial Vaginosis (BV):
  • Used as a vaginal acidifying agent to restore normal vaginal pH and flora, either as a monotherapy or in combination with antibiotics.

Off-label or Clinically Accepted Uses:

• Chemical Peels (Aesthetic Dermatology):
  • Utilized in various concentrations for superficial to medium-depth skin resurfacing.
• Wound Healing (Topical):
  • Occasionally used in dressings to maintain an acidic environment and support tissue regeneration.

Topical Administration:

Adults and Adolescents (≥12 years):

• Apply Lactic Acid 5% to 12% cream, lotion, or gel once or twice daily to affected areas.
• Rub gently until absorbed.
• For severe hyperkeratosis, higher concentrations (up to 12%) may be used under medical supervision.

Pediatric Patients (<12 years):

• Use under physician guidance. Begin with lower concentrations (e.g., 5%) once daily.

Intravaginal Administration:

Adults and Adolescents (≥12 years):

• Lactic Acid Vaginal Gel or Suppository (typically 0.074%–5%):
  Insert one applicatorful or one suppository into the vagina once daily at bedtime for 5 to 7 days.
• For recurrence prevention, use 2 to 3 times per week as maintenance, as directed by a healthcare provider.

Elderly Patients:

• No dosage adjustment required.

Renal or Hepatic Impairment:

• No dose adjustment necessary, as the drug is not systemically absorbed.

Lactic acid is an alpha-hydroxy acid (AHA) that acts as a keratolytic and humectant. When applied topically, it reduces corneocyte cohesion within the stratum corneum by disrupting ionic bonds, facilitating exfoliation and promoting smoother skin. It also increases epidermal hydration by attracting water into the stratum corneum. When administered intravaginally, lactic acid restores the normal acidic vaginal environment (pH ~3.5–4.5), which promotes the growth of lactobacilli and suppresses pathogenic anaerobes, thereby aiding in the prevention and treatment of bacterial vaginosis.

Absorption:

• Minimal to no systemic absorption through intact skin or vaginal mucosa at therapeutic concentrations.

Distribution:

• Not systemically distributed due to local activity.

Metabolism:

• If absorbed, lactic acid is metabolized in the liver to pyruvate and subsequently enters the citric acid cycle.

Excretion:

• Metabolites are excreted as carbon dioxide via respiration and water via the kidneys.

Onset of Action:

• Clinical improvement in skin texture may begin within 1 to 2 weeks of regular topical use.
• Vaginal acidification typically begins within 24 hours.

Half-life:

• Not applicable; local, non-systemic effect.

Pregnancy:

• FDA pregnancy category not formally assigned.
• Topical use: Considered safe during pregnancy due to minimal systemic absorption.
• Vaginal use: May be used during pregnancy under medical supervision if clinically indicated.

Lactation:

• Safe for use during breastfeeding when applied topically to areas away from the breast.
• If used near the breast (e.g., chest), clean the area thoroughly before nursing.
• Vaginal use is not expected to affect the breastfed infant.

Caution:

• Limited human data are available; use only if clearly needed and under professional supervision.

• Primary Class: Alpha-Hydroxy Acid (AHA)
• Subclasses:
  • Keratolytic Agent
  • Humectant
  • Vaginal Acidifying Agent
  • Cosmetic Peeling Agent (dermatologic use)

• Known hypersensitivity to lactic acid or any component of the formulation
• Application to inflamed, broken, or infected skin unless directed by a healthcare provider
• Severe vulvovaginal irritation or ulceration (for vaginal formulations)
• Concurrent use with other strong topical irritants without professional guidance

• Irritation Risk: May cause stinging, redness, or peeling, especially on sensitive skin or mucosa.
• Photosensitivity: Increases skin sensitivity to sunlight. Recommend sun protection during use.
• Ocular Exposure: Avoid contact with eyes; rinse thoroughly with water if accidental contact occurs.
• Vaginal Use: Avoid during menstruation or in presence of open vaginal lesions unless directed.
• Pediatric Use: Use with caution in children; prolonged or high-concentration use should be monitored.
• Perform patch testing before widespread use in individuals with sensitive skin or eczema history.

Common (Topical):

• Local irritation: Burning, stinging, redness, dryness, peeling
• Itching or mild discomfort at the application site

Common (Vaginal):

• Vaginal burning, itching, increased discharge, mild irritation

Uncommon to Rare:

• Contact dermatitis
• Allergic rash or hypersensitivity reaction
• Post-inflammatory hyperpigmentation or skin sensitivity with prolonged use

Severity:

• Generally mild and dose-dependent. Most effects subside with continued use or dose reduction.

Topical Drug Interactions:

• Concurrent use with other exfoliating agents (e.g., salicylic acid, benzoyl peroxide, retinoids) may increase skin irritation.
• Topical corticosteroids may reduce efficacy if applied concurrently.

Vaginal Drug Interactions:

• May alter the effectiveness of vaginal antifungal agents or spermicides when used simultaneously.
• Avoid mixing with other intravaginal medications unless advised.

Enzyme Systems:

• Lactic acid is not metabolized via the CYP450 system and does not affect hepatic enzymes.

Food and Alcohol Interactions:

• Not applicable for topical or vaginal routes.

• Dermatology: Lactic acid remains a recommended first-line treatment for xerosis and keratosis pilaris in updated dermatologic guidelines.
• Gynecology: European and global guidelines support the use of lactic acid vaginal gels as adjunct or maintenance therapy for bacterial vaginosis.
• Cosmetic Use: Increasing endorsement of lactic acid as a safe, effective agent for chemical peels in skin brightening and photoaging.

Topical Formulations:

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Do not freeze.
• Keep containers tightly closed and away from direct sunlight.

Vaginal Formulations:

• Store below 25°C (77°F) or as specified on the label.
• Some may require refrigeration after opening.
• Use applicator as directed and avoid contamination.

Handling Precautions:

• For external use only.
• Avoid contact with eyes, mucous membranes (unless vaginal product), and broken skin unless directed.