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CTRI Number  CTRI/2021/08/035763 [Registered on: 18/08/2021] Trial Registered Prospectively
Last Modified On: 18/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   NGP-01 gel for the treatment of Psoriasis 
Scientific Title of Study   A double blind, randomized, parallel group study to evaluate efficacy and safety of NGP-01 gel against placebo in the treatment of mild to moderate Psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NUTRIN005 Version 2.0 dated 11 May 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rupali Mali 
Designation  Principal Consultant 
Affiliation  Lokmanya Medical Research Centre & Lokmanya Hospital 
Address  Dept of Infectious Disease, Ground Floor, 314/B, Telco Road, Chinchwad, Pune 411033

Pune
MAHARASHTRA
411033
India 
Phone    
Fax    
Email  rupalimali387@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Puneet Mittal 
Designation  Director Clinical Research 
Affiliation  Mittal Global Clinical Trial Services 
Address  Suite 311, 3rd Floor, Tower B, iThum Business Park, A 40, Sector 62, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Details of Contact Person
Public Query  
Name  Puneet Mittal 
Designation  Director Clinical Research 
Affiliation  Mittal Global Clinical Trial Services 
Address  Suite 311, 3rd Floor, Tower B, iThum Business Park, A 40, Sector 62, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Source of Monetary or Material Support  
Galaxa Pharma, Korskildelund 6, 2670 Greve, Denmark 
Nutrin GmbH,Schnaid 36B, 91352 Hallerndorf, Germany 
 
Primary Sponsor  
Name  Nutrin GmbH 
Address  Schnaid 36B, 91352 Hallerndorf, Germany 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhijit Munshi  Lokmanya Medical Research Centre & Lokmanya Hospital  Dept of Infectious Disease, Ground Floor, 314/B, Telco Road, Chinchwad, Pune 411033
Pune
MAHARASHTRA 		 9822371703

drabhijitmunshi@gmail.com 
Dr Payal Mathur  Mavens Hospital  N 37, Opp. Reliance Fresh Lane, Sagar Vihar Colony, Vaishali Nagar, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN 		 9413824905

drpayalmathur@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Mavens Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L40||Psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NGP-01 Gel  1-2 ml NGP-01 gel to apply 2 times a day, Topical Use, for upto 3 months 
Comparator Agent  Placebo  1-2 ml Placebo gel to apply 2 times a day, Topical Use, for upto 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Are ≥18 to ≤65 years of age
2. Have a clinical diagnosis of mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical treatment that covers a minimum of 1.0% and a maximum of 10% Body Surface Area (BSA), in the permitted treatment areas.
3. Are willing to treat all psoriasis occurring in the permitted treatment areas with only NGP-01 gel
4. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
6. Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the treatment areas during the treatment
period.
7. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
8. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
9. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
10. Are willing to refrain from treating restricted areas, which will be excluded from the PGA assessments and Body Surface Area (BSA) calculation. These areas are as follows: head, neck, fingernails, toenails, soles of feet, and palms of hands, axillae, or intertriginous areas. 
 
ExclusionCriteria 
Details  1. Have spontaneously improving or rapidly deteriorating plaque psoriasis, or pustular psoriasis as determined by the Investigator.
2. Have been treated, with prescription medication for plaque psoriasis, with no improvement in condition, within 60 days prior to the Baseline visit.
3. Are pregnant, breast-feeding, or planning to become pregnant during the study.
4. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
5. Are undergoing treatments with topical antipsoriatic drug products other than corticosteroids within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
6. Have open sores or open lesions in the treatment area(s).
7. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of plaque psoriasis.
8. Have participated in any interventional clinical trial in the previous 30 days.
9. Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances, or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
10. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
11. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
12. Plan to seek alternative treatment of any kind for their psoriasis, in the eligible treatment areas or otherwise, during the trial period. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of subjects achieving at least a 1-grade improvement in Physician’s Global Assessment (PGA) score  Baseline to Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of subjects achieving a 2-grade improvement in the Physician’s Global Assessment (PGA) score  Baseline to Day 90 
Percentage of subjects who have a ≥ 25% reduction in the Psoriasis Area and Severity Index (PASI) score at any point during the trial.  Baseline to Day 90 
Percentage of subjects who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any point during the trial.  Baseline to Day 90 
Number of subjects achieving a Physician’s Global Assessment of “clear” or “almost clear”  Baseline to Day 90 
To assess the duration of treatment at intermediate & end point of treatment.  Baseline to Day 90 
To assess the safety and tolerability.  Baseline to Day 90 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Psoriasis is a common, immune-mediated, inflammatory skin disease that is found world-
wide. The prevalence of diagnosed psoriasis in the United States (US) is approximately 3% whereas the prevalence in Europe varies anywhere from 0.6 to 6.5% with an average of
approximately 3%. The clinical course is unpredictable, but in most cases, psoriasis is a chronically remitting and relapsing disease. Chronic stable plaque psoriasis (psoriasis vulgaris) is the most common form of the disease, accounting for 85-90 % of cases. Plaque- type psoriasis or psoriasis vulgaris is the most common form of the disease, and manifests as
raised, red, scaly patches with silver scales. The lesions are usually distributed symmetrically, and occur most commonly on the extensor parts of elbows and knees; scalp, lumbosacral region and umbilicus. Patients with psoriasis have reduced quality of life with reduced levels of employment and income, and studies have shown that patients with psoriasis are emotionally and physically impaired by their disease comparable to that seen with cancer,
heart disease, rheumatoid arthritis, diabetes or depression.

Individuals with psoriasis appear to be at an elevated risk of developing other chronic and
serious health conditions, such as metabolic syndrome/type 2 diabetes, cardiovascular
disease, psoriatic arthritis and other chronic inflammatory diseases.
There is no cure for psoriasis. The goal of treatment is to reduce or eliminate its signs and
symptoms. Mild to moderate disease is often treated with topical therapies. Sponsor has
developed the NGP-01 Gel containing the fixed dose combination of Dead Sea Salt,
Ethanol/water, Panthenol, Tocopheryl Acetate, Hydroxyethylcellulose, Isopropyl Myristate,
Retinyl Palmitate, Glycerin F, Aloe Barbadensis Leaf, Citric acid, without preservatives and
dyes. The Gel is easy to apply, and the cosmetic appearance is that of a white, milky gel,
easily-spreadable that absorbs completely into the skin a few minutes after application and it
is expected that the Gel will differentiate from marketed formulations by patient preference
for the gel and gel.
 
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