Evaluation of anti-inflammatory effects of curcumin which is encapsulated by niosomal nano-carrier in lesional skin of psoriatic patient: A pilot and clinical trial study
Evaluation of anti-inflammatory effects of encapsulated curcumin by niosomal nano-carrier in lesional skin of psoriatic patient
Design
Randomized, double-blind, placebo-controlled clinical trial in 10 patients (paired lesions)
Settings and conduct
The physician select patients at the skin clinic and medical pictures would be taken from skin lesion before and after treatment with drug and placebo for assessment of local disease severity. At the end of treatment skin punches are taken from the patients and then immune cells accumulation and also specific genes expression were evaluated by real time PCR. Blinding will be performed for patients, physician, and experimenter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Paired lesional skin of psoriatic patient with any infection or malignancy older than18 years
Exclusion criteria: pregnancy and lactation, suffering any other autoimmune and inflammatory disease
Intervention groups
The intervention group will apply the nano-curcumin ointment in specified lesional skin daily for four weeks and paired lesion of the same patients will apply a placebo in the same period for comparison of drug efficacy. Drug and placebo ointments would be constructed with the same features by a pharmacologist.
Main outcome variables
Expression of genes Ki67, βdefensin2, S100A12, S100A7, TNFα, IL23, IL22, IL17; Assessment of local disease severity; Immune cells accumulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181217042030N1
Registration date:2019-05-01, 1398/02/11
Registration timing:prospective
Last update:2019-05-01, 1398/02/11
Update count:0
Registration date
2019-05-01, 1398/02/11
Registrant information
Name
Ali Memarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 1644
Email address
alimemarian@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-inflammatory effects of curcumin which is encapsulated by niosomal nano-carrier in lesional skin of psoriatic patient: A pilot and clinical trial study
Public title
The therapeutic effect of nano-Curcumin on skin lesion of psoriasis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Parallel lesional skin of Psoriatic patient
lesions from mild or severe form of disease
Age >+18
Signing the informed consent form
Exclusion criteria:
Pregnant and lactation
Suffering from autoimmune or other inflammation diseases
Suffering from Cirrhosis and Hepatic disease
Suffering from Metabolic syndrome
Suffering from severe Renal disease
Allergic reaction to Curcumin
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
Skin punches from parallel and similar lesions in different area of body
Randomization (investigator's opinion)
Randomized
Randomization description
Since the patient lesions will be the study units and eligible patients have two similar lesions, one lesions will receives one of the interventions and the other comparison. By using a Randomizer software, on set of random numbers (i.e.1 to 10) will be generated. patient with odd number will receive intervention treatment on right lesion and comparison treatment on left lesion and patients with even number will receive intervention treatment on left lesion and comparison treatment on right lesion.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study blinding would be performed for patients and also for persons which do sampling and experiment. Randomization would be done by one colleague. Drug and placebo ointments would be applied for patients as a left or right drug, after taken an informed consent. Patients and the sampler (specialist) are not aware which treatments are received because drug and placebo would have same features and sampling will be done in the same way. Finally, researchers will receive samples only with the codes.
Placebo
Used
Assignment
Parallel
Other design features
This is a full-matched clinical trial study with with-in patient (internal) comparison group and the study unit are Lesions instead of patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Shast-Kola road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.GOUMS.REC.1397.275
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
IL23 gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
2
Description
IL17 gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
3
Description
TNFα gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
4
Description
IL22 gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
5
Description
s100A7 gene expresion
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
6
Description
s100A12 gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
7
Description
βefensin2 gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
8
Description
Ki67 gene expression
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Real time PCR and evaluating of gene expression exchange to control gene (18sRNA)
9
Description
Accumulation of immune cells in lesional skin tissue
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
H&E staining and optical microscopy
10
Description
Local disease severity
Timepoint
4 weeks after local treatment with encapsulated curcumin by noisome
Method of measurement
Observation by physician
Secondary outcomes
1
Description
Side effects (systemic and local)
Timepoint
A phone number were given to patients for any emmergency call during treatment. Patient could report any side effects 24/7 as well as during follow-ups, all the way through the treatment and after completion
Method of measurement
Medical examination by the consultant dermatology
Intervention groups
1
Description
Intervention group: patients were instructed to apply the niosome-curcumin ointment of 5 micromolar curcumin once a day for 4 weeks on their eligible skin lesions
Category
Treatment - Drugs
2
Description
Comparison group: patients were instructed to apply the placebo ointment (curcumin without niosome) once a day for 4 weeks on eligible skin lesions