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Lactic Acid

This article discusses various clinical trials investigating the use of lactic acid in skin care and hygiene products. These studies aim to evaluate the efficacy, safety, and potential benefits of lactic acid-containing formulations for different skin conditions and personal care applications. The trials cover a range of products, including moisturizing creams for dry skin in older adults and intimate hygiene products for women.

Table of Contents

What is Lactic Acid?

Lactic acid is a compound that has been studied extensively for its use in various hygiene products. It’s important to note that the lactic acid discussed in these clinical trials is not the same as the lactic acid produced in your muscles during exercise. Instead, it’s a specially formulated ingredient used in personal care products.[1][2]

Uses and Applications

The primary use of lactic acid in the context of these studies is for personal hygiene. It’s been incorporated into various products designed for intimate care, including:

  • Dermacyd Infantile: A product specifically formulated for infants[1]
  • Dermacyd Silver Frutal: A product with a fruity scent[3]
  • Dermacyd Silver Floral: A product with a floral scent[4]
  • Other variations like Dermacyd PH_DESILSTY_FL and Dermacyd PH_DESILSTY_FR[6][9]

These products are not intended to treat specific diseases but rather to maintain proper hygiene and potentially promote overall intimate health.

Safety and Acceptability

A significant focus of the clinical trials was to evaluate the safety and acceptability of lactic acid-based products. The studies aimed to demonstrate:

  • Absence of irritation[1]
  • Good acceptability by users[7]
  • Lack of primary and accumulated dermic irritability (skin irritation over time)[5]
  • Absence of allergic potential (sensitization)[5]

Researchers used specific scales to measure the intensity of any reactions, ensuring the products were safe for regular use.[1]

Photo Evaluation Studies

Several studies focused on the photo-related effects of lactic acid products. These evaluations aimed to ensure that the products wouldn’t cause adverse reactions when the skin was exposed to light, particularly UV radiation. The studies examined:

  • Photo-irritation potential: Whether the product causes skin irritation when exposed to light[2]
  • Photosensitization potential: Whether the product makes the skin more sensitive to light[3]

These tests used UVA irradiation and evaluated results according to the International Contact Dermatitis Research Group (ICDRG) scale. They also considered the individual’s skin type in assessing sensitivity.[4]

Application Methods

The lactic acid products were typically applied in one of two ways:

  • Like a curative: This means the product was applied directly to the skin, similar to how you might apply a lotion or ointment[3]
  • Normal conditions of use: This likely refers to using the product as directed, such as during regular bathing or hygiene routines[1]

Duration of Treatment

The duration of treatment varied across studies, but common timeframes included:

  • 21 consecutive days: Often used for acceptability studies[7][8]
  • 5 weeks: Typically used for photo-evaluation studies[2][3]
  • 6 weeks: Used in some compatibility studies[5]

Product Variations

The clinical trials examined several variations of lactic acid-based products, each potentially tailored for different uses or preferences:

  • Dermacyd Infantile: Specifically designed for infants[1]
  • Dermacyd Silver Frutal: A fruity-scented version[3]
  • Dermacyd Silver Floral: A floral-scented version[4]
  • Dermacyd PH_DESILSTY_FL: Another floral variant[6]
  • Dermacyd PH_DESILSTY_FR: Another fruity variant[9]

These variations suggest that while the core ingredient (lactic acid) remains the same, the products are formulated to cater to different preferences and age groups, from infants to adults.

Aspect Details
Main Products Studied 12% Ammonium Lactate cream, Dermacyd product line (various formulations)
Key Conditions Xerosis Cutis (dry skin), general hygiene
Primary Outcomes Measured Skin hydration, barrier function, irritation potential, photosensitivity
Measurement Tools SRRC score, Corneometer, Tewameter, ICDRG scale
Study Durations 4-6 weeks typically
Safety Assessments Irritation, contact dermatitis, folliculitis, miliaria, pruritus
Special Tests Photoirritation and photosensitization evaluations

FAQ

  • What skin conditions are being studied with lactic acid products? The clinical trials are studying lactic acid products for various skin conditions, including xerosis cutis (dry skin) in older adults and general hygiene purposes. One study specifically compares a 12% ammonium lactate cream with a 10% urea cream for treating dry skin in geriatric patients.
  • Are there any side effects associated with lactic acid products in these trials? The trials are designed to evaluate the safety of lactic acid products. They monitor for potential side effects such as irritation, contact dermatitis, folliculitis, and miliaria. Some studies also assess for symptoms like pruritus (itching), soreness, or stinging sensations.
  • How is the effectiveness of lactic acid products measured in these trials? The effectiveness is measured using various methods, including symptom scoring systems (like the Specified Symptom Sum Score or SRRC), skin capacitance measurements to assess hydration, and transepidermal water loss (TEWL) to evaluate skin barrier function. Some trials also use dermatological evaluations and scales to assess irritation or sensitivity.
  • What types of lactic acid products are being studied? The trials include a range of lactic acid products such as moisturizing creams (e.g., 12% ammonium lactate), intimate hygiene products (e.g., Dermacyd product line), and various formulations designed for different purposes and skin types.
  • How long do these clinical trials typically last? The duration of the trials varies. Some studies last for 4-5 weeks with follow-up assessments, while others may extend to 6 weeks. The timeframes are designed to allow for adequate evaluation of both short-term effects and potential cumulative impacts of the products.

Ongoing Clinical Trials on Lactic Acid

  • Study on the Safety and Effectiveness of PolyCore (Xylitol, L-Carnitine, Polydextrin) for Patients with End-Stage Kidney Disease Starting Peritoneal Dialysis

    Recruiting

    2 1 1
    Investigated drugs:
    Italy

  • Study on Peritoneal Ultrafiltration with PolyCore for Patients with Congestive Heart Failure Using Levocarnitine and Drug Combination

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Xerosis Cutis: A medical term for abnormally dry skin, which is common in older adults and can cause discomfort and itching.
  • Ammonium Lactate: A compound made from lactic acid and ammonia, often used in moisturizers to treat dry, scaly skin conditions.
  • Transepidermal Water Loss (TEWL): The amount of water that evaporates through the skin, used as a measure of the skin's barrier function.
  • Skin Capacitance: A measurement of the skin's ability to hold moisture, used to assess hydration levels.
  • Corneometer: A device used to measure skin hydration levels by assessing the skin's electrical properties.
  • Tewameter: An instrument used to measure transepidermal water loss from the skin.
  • Photoirritation: An irritation of the skin caused by the interaction between a substance and ultraviolet light.
  • Photosensitization: An allergic reaction triggered by the interaction between a substance on the skin and exposure to light.
  • UVA irradiation: Exposure to ultraviolet A light, used in some studies to test for potential light-related skin reactions.
  • International Contact Dermatitis Research Group (ICDRG) scale: A standardized scale used to evaluate and grade skin reactions in dermatological studies.

References

  1. https://clinicaltrials.gov/study/NCT00881270
  2. https://clinicaltrials.gov/study/NCT00881348
  3. https://clinicaltrials.gov/study/NCT00933075
  4. https://clinicaltrials.gov/study/NCT00932984
  5. https://clinicaltrials.gov/study/NCT00881374
  6. https://clinicaltrials.gov/study/NCT00933842
  7. https://clinicaltrials.gov/study/NCT00933413
  8. https://clinicaltrials.gov/study/NCT00933569
  9. https://clinicaltrials.gov/study/NCT00933257
  10. https://clinicaltrials.gov/study/NCT00933699