Uremic pruritus in hemodialysis patients Skin and Connective Tissue Diseases Pruritus, unspecified
Conditions
Interventions
Patients received information regarding the study protocol, its rationale and the potential risks (in Thai language) as well as sericin cream and cream base formulation. Signed informed consent was ob
Sponsors
National Research Council (Thailand)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients over 18 years of age with chronic kidney disease (CKD) 2. Patients who had received hemodialysis for at least three months were screened for this study 3. Mild to severe pruritis, according to the VAS, during the previous 6 weeks 4. Patients had to be willing to refrain from any antipruritic treatment, oral or topical, for a period of not less than 2 weeks prior to the start of the study. 5. Patients of both genders, regardless of comorbidities or prescribed medications Any medication that had antipruritic effect was discontinued 1 week before the study. No change in the medication prescription of patients was required during this study, with the exception of concomitant antipruritic treatment.
Exclusion criteria
Exclusion criteria: 1. Causes of pruritis from any other skin disease or from any medication 2. Patients with a history of silk protein allergy or who were allergic to any compounds in the formula 3. Patients who had biliary atresia, liver problems, cancer, metabolic disorders or other diseases related to systemic pruritis 4. Participants also left the project when they could not comply with the treatment, were unwilling to continue with the study or when the physician opined that other treatments were needed to relieve the symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of skin hydration on both arms and legs was assessed using a Corneometer while skin irritation or erythema (measured by the redness of the skin) and skin pigmentation (measuring the melanin content) were assessed using a mexameter linked to Skin Diagnostic SD27 (Courage + Khazaka electronic GmbH, Köln, Germany). The same measuring probe is also used to quantify skin redness (erythema) and to determine skin pigmentation or the degree of skin tanning (melanin). Also, the irritating effects of cosmetics as well as the soothing effects of active agents can also be recorded. Each parameter was measured at least three times in the same randomized area and the mean value was used for analysis. During the study, all patients were advised to consume similar kinds and amounts of food and beverages. Different activities or travelling was to be avoided in order to reduce any confounding factors. The percentage changes in each parameter were calculated by subtracting the baseline score from the post-treatment score on weeks 2, 4 and 6 according to the following equation: Percentage changes in each parameter = [(Pt - P0)/P0] * 100, where P0 is the value of each parameter at baseline (at the time of enrollment) and Pt is the value of each parameter during the follow-up period (2, 4 or 6 weeks). All measurements were performed in triplicate. The severity of itching was systemically assessed in all patients on both the arms and legs, using the visual analogue scale (VAS), on the day of enrollment and every 2 weeks after treatment began. We used the VAS consisting of a 10-cm horizontal line with no scale markings. The patients were asked to mark the intensity of their itching on the scale, with the strongest possible level of itching marked on the right end of the line (10 cm) and no itching marked on the left end (0 cm). Safety Monitoring Any allergic reaction to the silk sericin cream, which can occur, was regularly evaluated by two dermatologists during each visit. T | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients? Quality of Life Quality of life was assessed using the Thai version of the Kidney Disease Quality of Life Short Form (KDQOL-SF) Version 1.3, which was used to evaluate the patients on the day of enrollment and after 6 weeks of treatment. Mean scores were compared for individual domain scores and for the three composite summary scores, namely the mental component score (MCS), the physical component score (PCS) and the kidney-disease component score (KDCS). For the Hayes algorithm, the raw data obtained from the patients were first transformed into a pre-coded numerical value of 0-100, where a higher transformed score reflected a better quality of life. | — |
Countries
Thailand
Outcome results
None listed