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Laclotion (Ammonium Lactate Topical) - Summary

 



LACLOTION SUMMARY

LAClotion™ (ammonium lactate) lotion specially formulates 12% lactic acid, neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5-5.5. LAClotion™ also contains light mineral oil, glyceryl stearate, PEG-100 stearate, propylene glycol, polyoxyl 40 stearate, glycerin, magnesium aluminum silicate, laureth-4, cetyl alcohol, methyl and propyl parabens, methylcellulose, and water.

LAClotion™ is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.


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NEWS HIGHLIGHTS

Published Studies Related to Laclotion (Ammonium Lactate Topical)

A double-blind clinical trial comparing the efficacy and safety of pure lanolin versus ammonium lactate 12% cream for the treatment of moderate to severe foot xerosis. [2003.01]
Xerotic skin is a pattern of reaction to a variety of disorders (eg, winter xerosis, hereditary ichthyosis) with abnormalities of desquamation in common. The trial described in this article was a double-blind randomized-comparison clinical trial investigating the effect of pure lanolin versus ammonium lactate 12% cream in treating moderate to severe foot xerosis...

Clinical evaluation of 40% urea and 12% ammonium lactate in the treatment of xerosis. [2002]
BACKGROUND: Urea and ammonium lactate are used for the treatment of xerosis, with different degrees of success. This study compares the clinical effectiveness of these two agents... DISCUSSION: At day 14 of treatment, 40% urea cream was superior to 12% ammonium lactate for most of the instrumental and clinical assessments.

Comparison of salicylic acid and urea versus ammonium lactate for the treatment of foot xerosis. A randomized, double-blind, clinical study. [1998.07]
Xerosis is defined as dehydration of skin characterized by redness, dry scaling, and fine crackling that may resemble the crackling of porcelain. The present double-blind trial was a randomized paired comparison study evaluating the keratolytic effect of 5% salicylic acid and 10% urea ointment (Kerasal) on one foot and 12% ammonium lactate lotion (Lac-Hydrin) on the other foot in mild-to-moderate xerosis...

A randomized, double-blind, placebo-controlled study to evaluate the efficacy in AD of liquid soap containing 12% ammonium lactate + 20% urea. [2009.05.26]
Summary Atopic dermatitis (AD) is a common chronic skin disease, which mainly affects children... The liquid soap was found to be effective in patients with AD, as use of this soap in patients with stable mild to moderate AD improved the parameters studied.

Topical therapy with tretinoin and ammonium lactate for acanthosis nigricans associated with obesity. [2003.01]
Acanthosis nigricans (AN) is a cutaneous marker of various underlying systemic conditions.The following is a report of the successful use of a combination of 12% ammonium lactate cream and 0.05% tretinoin cream to treat AN associated with obesity.

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Clinical Trials Related to Laclotion (Ammonium Lactate Topical)

Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats [Completed]
Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Effect of Metformin on Lactate Metabolism [Completed]
The main objective of this study is to evaluate the influence of metformin on lactate metabolism.

The main outcome is the lactate production following an exogenous lactate overload in healthy male subjects without metformin and one week later with metformin.

The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients [Completed]
Previous clinical trials with 11. 2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride. It also does not cause hyperchloremic acidosis, which is of value in treating shock patients.

The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events. The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.

Early Lactate-Directed Therapy in the Intensive Care Unit (ICU) [Completed]
Blood lactate levels have long been related to tissue hypoxia, a severe condition in critically ill patients associated with the development of organ system failure and subsequent death. Increased blood lactate levels and failure to normalize blood lactate levels during treatment have been associated with increased morbidity and mortality. However, evidence of improved clinical outcome of lactate-directed therapy is limited and difference in the use of blood lactate monitoring in the intensive care unit exists between hospitals. This warrants a study on the efficacy of early blood lactate-directed therapy. In this study the efficacy of 8 hours of early lactate-directed therapy (therapy aimed at resolving tissue hypoxia that is guided by serial blood lactate levels) will be compared with 8 hours of control group therapy (without lactate measurement).

Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis [Recruiting]
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0. 05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.

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Page last updated: 2009-10-20

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