Recruitment of adults with moderate eczema for a randomised trial: Comparison of traditional versus modern methods.

BACKGROUND: Clinical trial recruitment is challenging for investigators who often overestimate the pool of qualified, willing subjects. Moreover, there is a paucity of literature, particularly in dermatology, regarding recruitment and the comparative success of advertising strategies. METHODS: Both 'traditional' (physician referral, newspaper and radio advertisements, letterbox drops, posters/flyers, word-of-mouth) and 'modern' (patient recruitment services, social media, Google advertisements, websites, email) recruitment methods were used to enrol 100 patients (>18 years) diagnosed with moderate eczema for a randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of a topical eczema treatment over 4 weeks. The relationships between recruitment method and patient age, sex, race, study completion and costs were analysed. RESULTS: The majority of patients recruited were young, with millennials and Gen Z comprising 77% of the study population. Both traditional and modern recruitment methods were equally successful in recruiting younger patients, with older patients predominately recruited by traditional methods. Eighty per cent more men were recruited by traditional compared to modern methods, whilst 67% more women than men were recruited by modern methods. Recruitment method neither appeared to be influenced by race, nor did it effect whether patients completed the study. Costs per enrolment were similar for both methods. CONCLUSIONS: This study shows that despite the high proportion of young patients and the rising popularity of social media and increased internet use, a combination of both traditional and modern recruitment methods was required to successfully meet the trial enrolment target of 100 adult patients with moderate eczema.

A daily regimen of a ceramide-dominant moisturizing cream and cleanser restores the skin permeability barrier in adults with moderate eczema: A randomized trial.

The dysfunctional skin barrier in eczema patients may be attributed to decreased levels of ceramides in the stratum corneum. The aim of this study was to determine whether a two-part system consisting of a ceramide-dominant physiological lipid-based moisturizing cream and cleanser could ameliorate the signs and symptoms of moderate eczema in adults over 28 days compared to placebo. Assessments were conducted at baseline and every 7 days thereafter. Eczema area severity index score decreased significantly across all time points in both groups compared to baseline (P < .0001), however, this decrease was not significant between groups at day 28 (P = .7804). In contrast, transepidermal water loss and skin hydration significantly improved over time in the active group, while it either stayed the same or worsened in the placebo group (P = .0342 and P < .0001, respectively). There was no difference in the use of mometasone furoate as rescue medication over time between groups (P = .1579). Dermatology life quality index scores improved significantly in both groups (P < .0001), with no difference between groups (P = .5256). However, patient satisfaction was greater in the active compared to the placebo group for several parameters including relief of itch, dry skin, skin softness and smoothness (all P < .05). No patients withdrew from the study due to adverse events (AEs) and there were no serious AEs. The ceramide-dominant moisturizing cream and cleanser safely restores skin permeability and improves the signs and symptoms of eczema in adults.

Emollient formulations containing antiseptics reduce effectively the level of Staphylococcus aureus on skin.

BACKGROUND: Increased skin colonization by Staphylococcus aureus is associated with atopic eczema (AE) severity. Reduction of S. aureus levels on the skin results in an improvement in the clinical condition. METHODS: The antimicrobial activity of topical products including a bath oil, cream, and wash combining antiseptics and emollients (A+E) was compared to products containing emollients only. The preference of patients with AE for A+E cream or emollient only cream to relieve symptoms of itching, erythema, and inflammation when applied three times daily for 10 days is evaluated. Repeat insult patch testing of the products is also conducted. RESULTS: A significant reduction in microbial counts was found following use of A+E bath oil (4.09±0.32 vs 6.20±0.24 log10 cfu/mL S. aureus, P<0.001), A+E cream (5.50±0.63 vs 5.94±0.72 log10 cfu/foot S. aureus, P=0.002), and A+E wash (2.71±0.48 vs 3.57±0.31 log10 cfu/mL Escherichia coli, P<0.001) compared to the emollient only products. The A+E cream was preferred to the emollient only cream (P=0.004) by patients with AE. All three tested formulations were found to be non-irritating and non-sensitizing to the skin. CONCLUSION: The bath oil, cream, and wash containing antiseptics and emollients decrease the level of bacteria on the skin, including S. aureus, compared to emollient only products. Patients with AE preferred the A+E cream compared to the emollient only cream to relieve symptoms of itching, erythema, and inflammation. The choice of formulation allows clinicians and patients to choose a suitable product for the short-term treatment of eczema flare-ups caused by bacterial infections.

Skin hydration is significantly increased by a cream formulated to mimic the skin's own natural moisturizing systems.

BACKGROUND: Moisturizers are topical products designed to improve and maintain the skin barrier function and to help prevent dry skin. MATERIALS AND METHODS: A new moisturizer (Ceramide cream) was formulated containing ingredients which mimic the skin's own natural moisturizing systems. Corneometry was performed at baseline, 2, 4, 6 and 24 hours following a single application of Ceramide cream to healthy skin, and compared to three reference moisturizers available over-the-counter, and placebo. Transepidermal water loss (TEWL) was also measured following a single application of Ceramide cream compared to baseline, and its safety was assessed by repeat insult patch test, ophthalmologist and pediatric testing. RESULTS: A single topical application of either the Ceramide cream or the three reference moisturizers resulted in a significant increase in skin hydration over time (P<0.001). The placebo cream did not significantly increase skin hydration at any time point. At 24 hours post-application, skin hydration measured for Ceramide cream was significantly greater (P<0.05) than that measured for all three of the reference moisturizers tested. Ceramide cream was also found to significantly decrease TEWL (P<0.001) over 24 hours, and was shown to be non-sensitizing to the skin of both adults and children and non-irritating to the skin, eyes and related eye area. CONCLUSION: Ceramide cream increases skin hydration and improves barrier function which may make it suitable for use on dry skin.

Comparative safety and efficacy of topical mometasone furoate with other topical corticosteroids.

Derivatives of hydrocortisone, such as mometasone furoate, a (2') furoate-17 ester with chlorine substitutions at positions 9 and 21, have been designed to improve efficacy and reduce the incidence of adverse effects. An extensive literature search of MEDLINE, Embase and other databases was conducted to review the safety and efficacy of various formulations of topical mometasone furoate. Mometasone furoate exhibits high potency with greater anti-inflammatory activity and a longer duration of action than betamethasone. In clinical trials, mometasone furoate shows comparable or significantly better efficacy, depending on the comparator, in all indications studied in both adults and children. It is well tolerated with only transient, mild to moderate local adverse effects. It is characterised by low systemic availability due to its high lipophilicity, low percutaneous absorption and rapid hepatic biotransformation, and consequently has no significant effect on the hypothalamic-pituitary-adrenal axis. The molecular biotransformation of mometasone furoate in the skin results in a lower affinity with dermal cells than epidermal cells, which contributes to its low atrophogenicity. Sensitisation to mometasone furoate is low. Overall, mometasone furoate is a highly efficacious potent corticosteroid with a low risk of both local and systemic adverse effects.

The efficacy of Australian essential oils for the treatment of head lice infestation in children: A randomised controlled trial.

BACKGROUND: The increase in resistance of head lice to neurotoxic pediculicides and public concern over their safety has led to an increase in alternative treatments, many of which are poorly researched or even untested. METHODS: A multicentre, randomised, assessor-blind, parallel-group trial (Trial 1) was conducted to compare the safety and efficacy of a head lice treatment containing Australian eucalyptus oil and Leptospermum petersonii (EO/LP solution; applied thrice with 7-day intervals between applications) with a neurotoxic treatment containing pyrethrins and piperonyl butoxide (P/PB mousse; applied twice with a 7-day interval) in children. A single-blind, open trial (Trial 2) was conducted to assess the efficacy of EO/LP solution following a single application. In addition, skin irritancy and sensitisation tests using EO/LP solution were performed in adults and children. In vitro tests were performed to further assess the ovicidal and pediculicidal efficacy of EO/LP solution. RESULTS: EO/LP solution was found to be more than twice as effective in curing head lice infestation as P/PB mousse in per-protocol participants (Trial 1; 83% vs 36%, P < 0.0001), and was also found to be 100% pediculicidal following a single application (Trial 2). Adverse events were limited to transient itching, burning or stinging. Further skin testing with the EO/LP solution reported no irritation or sensitisation in adults, or irritation in children. In vitro exposure of lice and eggs to the EO/LP solution resulted in 100% mortality. CONCLUSION: The efficacy, safety and relative ease of use of the EO/LP solution make it a viable alternative in treating head lice.

Topical pine tar: History, properties and use as a treatment for common skin conditions.

Pine tar is the end product of pine wood carbonisation following distillation using extreme heat. An extensive literature search was conducted back to the 1950s for this review. Pine tar has been used in medicine for more than 2000 years to treat a range of skin conditions because of its soothing and antiseptic properties. Pine tar should not be confused with coal tar, which has been produced from coal for approximately a hundred years. Pine tar is thought to exert its effect by reducing DNA synthesis and mitotic activity, which promotes a return to normal keratinisation. In addition, pine tar has been shown to be antipruritic, anti-inflammatory, antibacterial and antifungal. These properties make pine tar suitable for the topical treatment of eczema, psoriasis, seborrhoeic dermatitis and other dry, itchy, flaky or inflamed skin conditions. Topical products available over-the-counter in Australia today contain up to 2.3% pine tar, and come in several different formulations that can be used on the entire body, including the face. Modern day pine tar is manufactured with increased purity to eliminate toxic phenol and carcinogenic components, which have been of concern in the past. Primary irritation is uncommon. In conclusion, the long experience with topical pine tar therapy and its worldwide usage, together with the evidence presented in this review, suggests that pine tar is an effective treatment with minimal safety risk.

Bioequivalence of 0.1% mometasone furoate lotion to 0.1% mometasone furoate hydrogel.

BACKGROUND/OBJECTIVES: Vehicles used for topical therapy can affect drug delivery and patient adherence. This study compared the bioequivalence of 0.1% mometasone furoate lotion (reference) and 0.1% mometasone furoate hydrogel (test). Moisturising capacity and sensitivity/irritancy potential were also determined. METHODS: Bioequivalence was assessed by vasoconstriction assay and analysis of area under the effect curve (AUEC0-24 ) according to the Food and Drug Administration (FDA) guidance. In total, 131 individuals were screened in a pilot dose duration-response study, and 90 responders enrolled. For the pivotal study, lotion and hydrogel (5 mg/cm(2) ) were applied in a double-blind manner. Vasoconstriction was evaluated by chromameter at 0, 2, 4, 6, 19 and 24 h following lotion and hydrogel removal. Barrier function was measured by assessment of transepidermal water loss (TEWL) and skin hydration. Sensitivity/irritancy potential was assessed by repeat insult patch tests. RESULTS: The mean AUEC0-24 of the test hydrogel and reference lotion were -18.200 and -18.953, respectively, with test/reference = 96%, with 90% confidence interval (0.81, 1.12), which was within FDA guidance limits. TEWL was found to significantly decrease by 43 and 29% after 2 and 24 h, respectively, while skin hydration significantly increased by 38% after 24 h following a single application of hydrogel. The hydrogel was also found to be non-irritating and non-sensitising. No adverse events were observed. CONCLUSIONS: Mometasone furoate hydrogel is bioequivalent to mometasone furoate lotion. This novel hydrogel formulation provides effective drug delivery, increases moisturisation and affords greater ease and tolerability of application, improving patients' adherence to therapy.

Evaluation of a topical treatment for the relief of sensitive skin.

BACKGROUND: Approximately, 50% of the population claim to have sensitive skin, which has created an important challenge for dermatologists and the cosmetic industry. This study evaluates the properties of QV Face Rescue Gel (Rescue Gel) that contains a combination of moisturizing and anti-irritant ingredients, and which is used to relieve the symptoms of sensitive facial skin. METHODS: The ability of Rescue Gel to induce collagen types I and III in cultured neonatal human foreskin fibroblasts compared to transforming growth factor beta 1, a known potent inducer of collagen types I and III, was measured using immunofluorescence staining. Furthermore, healthy volunteers were recruited to measure the potential for Rescue Gel to reduce erythema induced by solar-simulated ultraviolet radiation on the skin compared to 0.5% hydrocortisone cream (positive control) as well as it's ability to decrease transepidermal water loss compared to baseline levels. In addition, the formulation was tested for its potential to be 1) nonstinging using a facial sting/discomfort assay performed on volunteers who reacted positively to lactic acid, 2) nonirritating as determined by repeat insult patch tests, and 3) noncomedogenic. RESULTS: Rescue Gel significantly induced collagen types I and III in cultured human foreskin fibroblasts similarly to transforming growth factor beta 1. In volunteers, Rescue Gel was shown to significantly reduce erythema induced by solar-simulated ultraviolet radiation similarly to 0.5% hydrocortisone, and to significantly reduce transepidermal water loss compared to baseline levels. Further, the formulation was found to be nonstinging, nonirritating, and noncomedogenic. No adverse events were observed. CONCLUSION: In this study, Rescue Gel has been shown to exhibit properties that make it effective for use on sensitive or irritated facial skin, without exacerbation of the symptoms associated with sensitive skin.

An antiaging skin care system containing alpha hydroxy acids and vitamins improves the biomechanical parameters of facial skin.

BACKGROUND: The demand for antiaging products has dramatically increased in recent years, driven by an aging population seeking to maintain the appearance of youth. This study investigates the effects of an antiaging skin care system containing alpha hydroxy acids (AHAs) in conjunction with vitamins B3, C, and E on the biomechanical parameters of facial skin. METHODS: Fifty two volunteers followed an antiaging skin care regimen comprising of cleanser, eye cream, day moisturizer, and night moisturizer for 21 days. Wrinkle depth (Ry ) and skin roughness (Ra ) were measured by skin surface profilometry of the crow's feet area, and skin elasticity parameters R2 (gross elasticity), R5 (net elasticity), R6 (viscoelastic portion), and R7 (recovery after deformation) were determined for facial skin by cutometer, preapplication and after 7, 14, and 21 days. Volunteers also completed a self-assessment questionnaire. RESULTS: Compared to baseline, Ry and Ra significantly improved by 32.5% (P<0.0001) and 42.9% (P<0.0001), respectively, after 21 days of antiaging skin care treatment. These results were observed by the volunteers with 9 out of 10 discerning an improvement in skin texture and smoothness. Compared to baseline, R2 and R5 significantly increased by 15.2% (P<0.0001) and 12.5% (P=0.0449), respectively, while R6 significantly decreased by 17.7% (P<0.0001) after 21 days. R7 increased by 9.7% after 21 days compared to baseline but this was not significant over this time period. CONCLUSION: An antiaging skin care system containing AHAs and vitamins significantly improves the biomechanical parameters of the skin including wrinkles and skin texture, as well as elasticity without significant adverse effects.

Increased bioavailability of hydrocortisone dissolved in a cream base.

BACKGROUND/OBJECTIVES: The aim of this study was to compare vasoconstrictor activity and, by inference, the clinical anti-inflammatory effectiveness of hydrocortisone in two different formulations: 1% dissolved hydrocortisone cream and 1% dispersed hydrocortisone cream. Moisturising capacity and safety were also determined. METHODS: Both topical preparations were applied without occlusion on forearms twice daily for 5 days. An assessment of vasoconstriction was performed in a double-blinded manner pretreatment and then thrice daily for 6 days and once 7 days post-application, using an objective rating scale. For the dissolved preparation only, moisturising capacity was determined by measurement of transepidermal water loss (TEWL) at 0, 2, 4, 6 and 24 h, and also by the measurement of water content at 0 and 24 h. Safety was assessed by repeat insult patch tests (RIPT). RESULTS: In all, 10 volunteers completed the vasoconstrictor and moisturising studies, while 52 completed the RIPT. For 1% dissolved hydrocortisone cream and 1% dispersed hydrocortisone cream, respectively, areas under the blanching curves were 1240 and 295; total scores were 129.0 and 31.5; summed % total possible scores were 161.3 and 39.4; Tm/10 mean values were 3.47 and 1.64. The 1% dissolved hydrocortisone cream was found to be statistically more potent than the 1% dispersed hydrocortisone cream. Furthermore, the 1% dissolved hydrocortisone cream was found to be moisturising compared to no treatment. No adverse events were observed. CONCLUSIONS: A cream containing 1% dissolved hydrocortisone exhibits greater vasoconstrictor activity than a cream containing 1% dispersed hydrocortisone.

Use of bleach baths for the treatment of infected atopic eczema.

Atopic eczema is one of the most common skin disorders in young children and also affects adults. Staphylococcus aureus infection is the most frequent complication of atopic eczema and is involved in the worsening of the disease. Antibiotic therapy against S. aureus has been an important component of treatment for atopic eczema but there are concerns about antibiotic overuse and increasing bacterial resistance. This has led some clinicians to recommend the use of homemade remedies such as bleach baths as an adjunctive treatment for patients with infected atopic eczema, despite the fact that there have been few published studies in this area. Balancing safety concerns with efficacious treatment is of particular importance in the paediatric population. This review discusses the historical use of bleach in medicine as well as its recent use for atopic eczema. Further, the chemistry and safety of bleach as well as alternative therapies are examined.

Safety and efficacy of a non-pesticide-based head lice treatment: results of a randomised comparative trial in children.

BACKGROUND/OBJECTIVES: Increasing resistance to pesticide-based head lice treatments has resulted in the need for alternative products to treat head lice infestations, but there are few clinical studies that have adequately tested these products. This multicentre, randomised, assessor-blind, parallel-group phase IV trial compared the safety and efficacy of a non-pesticide-based head lice shampoo with malathion foam in children. METHODS: This trial used strict entry criteria, standardised treatment and assessment regimes, sibling control and a primary efficacy end-point defined as the absence of live head lice 21 days after initiating treatment. Repeat insult patch tests were performed to further assess the safety of the non-pesticide-based shampoo. In vitro tests were used to assess its ovicidal and pediculicidal efficacy. RESULTS: A total of 216 children were enrolled, of whom 172 were per-protocol. The non-pesticide-based shampoo was significantly more effective than malathion foam for the intent-to-treat population (62.3 vs 40.4% louse-free, unadjusted P = 0.002; adjusted P = 0.003), as well as for the per-protocol population (67.8 vs 43.0% louse-free, unadjusted P = 0.001; adjusted P = 0.004). Adverse events were limited to itching or stinging. Patch testing with the non-pesticide-based shampoo resulted in no adverse reactions. In vitro tests using body lice demonstrated that the non-pesticide-based shampoo is ovicidal and pediculicidal. CONCLUSION: The non-pesticide-based shampoo is significantly more effective in eliminating head lice than malathion foam in children, while being associated with a low incidence of mild, transient adverse events.

In vitro comparison of four treatments which discourage infestation by head lice.

Products which discourage the transmission of head lice are appealing; however, few studies have tested this concept. This study aims to test the efficacy of four commercial products which claim to discourage infestation by head lice; MOOV Head Lice Defence Spray (MOOV), Wild Child Quit Nits Head Lice Defence Spray (Wild Child), 100% Natural Head Lice Beater (Lice Beater) or Lysout Natural Anti-Lice Spray (Lysout). An in vitro challenge test was used. Briefly, one half of a filter paper lining the base of a petri dish was treated with the test product. Lice were then introduced to the centre of the dish, which was covered and placed in the dark at 20°C for 30 min. The number of lice on the treated and untreated sides of the filter paper was then counted after 2, 4 and 8 h post-application. MOOV was significantly more effective at discouraging the transmission of lice than the water control (p < 0.01), while Wild Child and Lysout were not at all time points. Lice Beater was significantly worse than the water control after 2 h (p < 0.01), while there was no difference after 4 and 8 h. MOOV was found to perform significantly better than Wild Child (p < 0.05) and Lice Beater (p < 0.05) at all time points. It also performed significantly better than Lysout at 2 (p < 0.05) and 8 h (p < 0.05), but not 4 h. MOOV offers the best efficacy and consistency of performance of the four products tested to discourage the transmission of head lice.

A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in children.

BACKGROUND/OBJECTIVES: There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant-based head lice treatment to malathion in children. METHODS: The trial used strict entry criteria, standardized treatment and assessment regimens, sibling treatment where appropriate and a primary efficacy end-point defined as the absence of live head lice. RESULTS: A total of 216 children were enrolled. One hundred and sixty-nine were per-protocol. The suffocant was significantly more effective than malathion for the intention-to-treat population (53.9% vs 40.4% louse-free, unadjusted P = 0.052; adjusted P = 0.024), as well as for the per-protocol population (57.8% vs 43.0% louse-free, unadjusted P = 0.054; adjusted P = 0.045). Adverse events were limited to itching or stinging and there were no serious or systemic adverse events. Repeat insult patch testing with the suffocant resulted in no adverse reactions. In vitro tests confirmed that the suffocant is a potent ovicide and pediculicide with 100% mortality of eggs and lice following a 20-min contact time. CONCLUSIONS: The suffocant is shown to be significantly more effective in eliminating head lice than malathion in children, while being associated with a low incidence of mild, transient adverse events.

Albumin fragments in normal rat urine are derived from rapidly degraded filtered albumin.

Filtered albumin is excreted as a heterogeneous population of albumin-derived molecules resulting from degradation during renal passage. In order to understand the dynamics of this degradation process, albumin clearance was studied over a short-term (minutes) and a long-term (7 days) by both radioactivity and radioimmunoassay. The radiolabelled material in the urine was also analysed extensively by using size exclusion chromatography, size selective filtration and high performance liquid chromatography. These studies demonstrate that during renal passage, albumin degradation to fragments in the size range of 500-10,000 occurs in a matter of minutes. The fragments are not detected by using radioimmunoassay. Steady state excretion rates or fractional clearance of radiolabelled albumin occur over a similar time period. Both rates of degradation and approach to steady-state clearance, while rapid, were considerably slower than the transit time for molecules in the Bowman's capsule and early tubular lumen. The results are consistent with an extremely rapid lysosomal uptake of filtered albumin, and degradation and regurgitation of the albumin-derived peptide fragments into the tubular lumen prior to excretion.

Nephrotic-like proteinuria in experimental diabetes.

AIMS/HYPOTHESIS: Streptozotocin (STZ) diabetic rats are characterized by the development of albuminuria. It is not known, however, whether the excess excretion of protein is primarily due to intact protein or protein fragments or whether it is specific for albumin or occurs for all high-molecular-weight plasma proteins. To test this we have measured the excretion rates and fractional clearances of [(14)C]albumin, [(3)H]immunoglobulin G and [(3)H]transferrin in diabetic rats. METHODS: The radiolabeled proteins were delivered to the circulation of conscious diabetic (STZ induced for 6 weeks) and control rats by ALZET osmotic pumps. The plasma level of the radiolabeled proteins reached steady-state levels by day 7. Urine and plasma samples from day 7 were used to determine the excretion rates of the proteins by radioactivity and radioimmunoassay. RESULTS: When excretion rates were determined by radioactivity it was apparent that only the albumin excretion rate increased significantly with STZ diabetes to a value of 354 +/- 166 microg/min which agrees with proteinuria determined by Biuret assay of 299.9 +/- 52.4 microg/min. The major proportion of protein being excreted was in the form of protein fragments which are not detected by conventional immmunochemical assays. CONCLUSION: The previously unrecognized nephrotic-like levels of proteinuria in experimental diabetes appears to be associated with an albumin-specific mechanism responsible for the increase in albumin peptides in urine. There was significant lowering of plasma albumin concentration but plasma concentrations of transferrin and immunoglobulin G remained unchanged. There was also no significant appearance of intact protein in urine that is normally found in nephrotic states.

Exogenous albumin peptides influence the processing of albumin during renal passage.

UNLABELLED: Exogenous albumin peptides influence the processing of albumin during renal passage. BACKGROUND/AIMS: This study investigates the hypothesis that there will be peptide regions in albumin that will effectively compete for the receptors associated with the renal processing of albumin. METHODS: We employ albumin peptides prepared from albumin by trypsin digestion. The presentation of the exogenous peptides along with intact [(3)H]albumin to the kidney was made by intravenous injection into rats. The excretion rate and integrity of urinary [(3)H]albumin was measured. Similar experiments were performed with the use of gelatin peptides produced by trypsin digestion as controls. The formation of [(3)H]albumin derived fragments by extrarenal sources was also examined in rats with nonfiltering kidneys. RESULTS: In the presence of exogenous albumin-derived peptides there was a significant increase in the proportion of larger [(3)H]albumin fragments in the urine. This is a reversible effect. There was no significant change when gelatin peptides were used. The albumin peptides also increase the fractional clearance of [(3)H]albumin. There were no [(3)H]albumin-derived fragments produced in plasma over a 4-hour circulation period in rats with nonfiltering kidneys. CONCLUSIONS: This study demonstrates that albumin fragments, which are produced by the kidney and not by extrarenal sources, are exclusively excreted in the urine. Exogenous albumin peptides were able to specifically exert a competitive effect on the renal enzyme cleavage of intact albumin.