Psoriasis Clinical Trial
Official title:
Development of a Novel Chinese Medicine Formula for the Treatment of Psoriasis: A Randomized, Double-blinded, Placebo-controlled Trial
Psoriasis is an inflammatory skin disease with huge negative impact on the quality of life of the patients, and has an overall prevalence of 2% to 3% in the general population. Plaques psoriasis is the most common type of the disease and presents red, well demarcated, and silvery plaques mainly localized in the umbilical and lumbosacral area as well as in the elbows, knees, and scalp. Currently, pharmacological treatments such as retinoids, corticosteroids, vitamin D analogs and biologics remain the main options for most psoriasis patients. However, side effect and high cost barred many ordinary psoriasis patients. A Chinese medicine formula "Inflammatory skin disease formula (ISDF)" was prescribed by Prof. Lin for many years and observed to be effective in relieving atopic dermatitis and psoriasis patients' clinical manifestations. In this study, subjects with psoriasis will be randomized into treatment group of "ISDF" or placebo group for 12 weeks.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 31, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Mild to moderate chronic plaque psoriasis (PASI score 3 to 12). - Willingness to give informed consent. Exclusion Criteria: - Pustular or generalized erythrodermic psoriasis. - Psoriatic arthritis with syndrome of spleen-kidney yang deficiency according to Chinese medicine theory. - Systemic therapy for psoriasis 6 months prior to baseline. - Use topical medications for psoriasis 14 days prior to baseline such as retinoids, corticosteroids, vitamin D analogues, tazarotene and tacrolimus. - Has taken any antibiotics, probiotics and prebiotics 30 days prior to baseline. - UV light therapy 30 days prior to baseline. - Clinically significant laboratory abnormality in blood, liver or renal functions (=1.5 times the upper limit of reference range). - History of allergy to Chinese herbs. - Unwillingness to comply with study protocol. - Any other condition that in the opinion of the investigators could compromise the study. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Hong Kong Institute of Integrative Medicine | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psoriasis Area and Severity Index (PASI) | The change in Psoriasis Area and Severity Index (PASI) score will be assessed. PASI scores include area involved, erythema, induration and scaling. It will be scored on a scale of 0 to 4 (0, meaning none; 1, mild; 2, moderate; 3, severe; and 4, very severe). It will be performed by 2 blinded assessors who have been trained. Four main areas were assessed for calculation of the PASI scores: the head, the trunk, the upper extremities, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The maximum score for PASI is 72. | Week 12 | |
Primary | Static Physician Global Assessment score (sPGA) | Participants are requested to expose their skin thoroughly before the photographs are taken at each visit. The sPGA is an investigator-rated assessment of overall disease severity to be evaluated on a 5-point scale, where 0=clear and 4=severe. The severity of erythema, scaling, and plaque are considered for assessment. It will be performed by 2 blinded assessors who have received training. | Week 12 | |
Secondary | Psoriasis Area and Severity Index (PASI) | The change in Psoriasis Area and Severity Index (PASI) score will be assessed. PASI scores include area involved, erythema, induration and scaling. It will be scored on a scale of 0 to 4 (0, meaning none; 1, mild; 2, moderate; 3, severe; and 4, very severe). It will be performed by 2 blinded assessors who have been trained. Four main areas were assessed for calculation of the PASI scores: the head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The maximum score for PASI is 72. | Week 6 | |
Secondary | Psoriasis Area and Severity Index (PASI) | The change in Psoriasis Area and Severity Index (PASI) score will be assessed. PASI scores include area involved, erythema, induration and scaling. It will be scored on a scale of 0 to 4 (0, meaning none; 1, mild; 2, moderate; 3, severe; and 4, very severe). It will be performed by 2 blinded assessors who have been trained. Four main areas were assessed for calculation of the PASI scores: the head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The maximum score for PASI is 72. | Week 18 | |
Secondary | Static Physician Global Assessment score (sPGA) | Participants are requested to expose their skin thoroughly before the photographs are taken at each visit. The sPGA is an investigator-rated assessment of overall disease severity to be evaluated on a 5-point scale, where 0=clear and 4=severe. The severity of erythema, scaling, and plaque are considered for assessment. It will be performed by 2 blinded assessors who have received training. | Week 6 | |
Secondary | Static Physician Global Assessment score (sPGA) | Participants are requested to expose their skin thoroughly before the photographs are taken at each visit. The sPGA is an investigator-rated assessment of overall disease severity to be evaluated on a 5-point scale, where 0=clear and 4=severe. The severity of erythema, scaling, and plaque are considered for assessment. It will be performed by 2 blinded assessors who have received training. | Week 18 | |
Secondary | Impact of Psoriasis Questionnaire (IPSO) | The change in Impact of Psoriasis Questionnaire (IPSO) score will be assessed. IPSO is a validated 16-item psoriasis-specific instrument for quality of life of psoriasis patients. The IPSO is intended predominantly to assess the psychosocial impact of psoriasis on patient's lives. The IPSO uses an ordinal rating scale, with responses of 'none', 'some', 'moderately', 'quite a bit' and 'extremely' scored 1, 2, 3, 4 and 5, respectively. The scores for item 4 were reversed. The higher the summed score, the greater the impact experienced due to psoriasis. | Week 12 | |
Secondary | Short Form 36 survey (SF36) | The change in the score of quality of life using Short Form 36 survey (SF36) will be assessed. SF36 is generic instrument to measure general health status that is complementary to those derived from dermatological questionnaires. It will be used to assess the patient's health status using 8 different dimensions including vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical health, role limitations due to emotional health, social role functioning and mental health. The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions. | Week 12 | |
Secondary | Use of rescue therapy | The frequent use of rescue therapy during study period | Up to Week 18 | |
Secondary | Adverse events | Adverse events related to study treatment | Up to Week 18 | |
Secondary | Serum markers (IL-17A, IL-22, IL-23, CRP and BD-2) | The changes in levels of serum markers [IL-17A, IL-22, IL-23, C-reactive protein (CRP) and Beta-Defensin 2 (BD2)]. | Week 12 | |
Secondary | Oral and Gut microbiota composition in saliva and stools | The changes in the oral and gut microbiota composition in saliva and stools | Week 12 | |
Secondary | Psoriasis Itch Visual Analog Scale (Itch VAS) | Psoriasis itch VAS is a validated tool to assess treatment benefit of plaque psoriasis. It was developed to measure itch intensity within the last 24 hours. A horizontal line with a length of 100mm is to be used to represented the range of itch intensity from 0 (no itch at all) to 100 (worst itch you can imagine). Subjects rated the maximal intensity of itch during the previous 24 hours by putting a vertical mark through the horizontal line at the the spot he/she felt best reflected their maximal itch intensity. | Week 12 | |
Secondary | Psoriasis-involved body surface area (BSA) | BSA represents the affected skin surface. It is an objective measure of psoriasis severity. The head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The range of BSA is 0-100. It will be performed by 2 blinded assessors who have received training. | Week 6 | |
Secondary | Psoriasis-involved body surface area (BSA) | BSA represents the affected skin surface. It is an objective measure of psoriasis severity. The head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The range of BSA is 0-100. It will be performed by 2 blinded assessors who have received training. | Week 12 | |
Secondary | Psoriasis-involved body surface area (BSA) | BSA represents the affected skin surface. It is an objective measure of psoriasis severity. The head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The range of BSA is 0-100. It will be performed by 2 blinded assessors who have received training. | Week 18 |
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