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CTRI Number  CTRI/2020/12/029971 [Registered on: 22/12/2020] Trial Registered Prospectively
Last Modified On: 15/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate Dermatitis Lotion for treatment of Atopic Dermatitis in Children 
Scientific Title of Study   Evaluation of efficacy and safety of Dermatitis Lotion in the treatment of Atopic Dermatitis in Children: A prospective, single center, interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SBS/AWPL/DLC/072051 Version 1.0 Date: 31st July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dasiga Venkatasubramanya Pratap 
Designation  Consultant Dermatologist 
Affiliation  Kakatiya Hospital 
Address  Department of Dermatology, Kakatiya Hospital, Road No.2, P&T Colony, Medipally, Uppal, Hyderabad

Hyderabad
TELANGANA
500039
India 
Phone  9848031921  
Fax    
Email  pratapdasiga1953@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr C M Reddy 
Designation  Chief Scientific Officer 
Affiliation  Amitojas Wellness Private Limited 
Address  #3-100-55/739, Block-A,2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad

Hyderabad
TELANGANA
500014
India 
Phone  8885324455  
Fax    
Email  cso@amitojas.com  
 
Details of Contact Person
Public Query  
Name  Mr Kamal Kammili 
Designation  Director - Operations 
Affiliation  Sanjeevani Bio Services Private Limited  
Address  3rd Floor, Plot No. 28B, Raghavendra Colony, Kondapur, Hyderabad

Hyderabad
TELANGANA
500084
India 
Phone  04048593559  
Fax    
Email  kamal.kammili@sanjeevanibio.com  
 
Source of Monetary or Material Support  
Amitojas Wellness Private Limited  
 
Primary Sponsor  
Name  Amitojas Wellness Private Limited 
Address  2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad, Telangana – 500014, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dasiga Venkatasubramanya Pratap  Kakatiya Hospital  Department of Dermatology, Kakatiya Hospital, Road No.2, P&T Colony, Medipally, Uppal, Hyderabad Hyderabad
Hyderabad
TELANGANA 		 9848031921

pratapdasiga1953@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kakatiya Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dermatitis Lotion  The investigational product, Dermatitis Lotion is a nutraceutical product, formulated as a lotion which has Omega - 3 fatty acid oil (Seabuckthorn oil), Probiotic Lysate (Streptococcus thermophilus), Wheat sprout extract (ceramosides), Shea Butter, Oatmeal extract, Astaxanthin, Fermented ginger extract, Liposomal Curcumin, Biotin, Natural Vitamin E. Required quantity of the lotion is to be applied on dermatitis affected areas twice daily for 90 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Male and female children aged ≥ 6 months to ≤12 years.
2. Subject diagnosed with Atopic Dermatitis as per the medical judgement of the study investigator.
3. Subject with mild to severe eczema as determined by the Patient-Oriented Eczema Measure (POEM) score.
4. Children willing to provide informed assent if applicable.
5. Child’s parent/guardian/legally acceptable representative willing to provide informed written consent. 
 
ExclusionCriteria 
Details  1. Children with significant medical/surgical condition which requires long-term treatment.
2. Children with genetic diseases, congenital diseases and mentally challenged.
3. Children who are currently being treated with other atopic dermatitis drugs.
4. Subject has clinically infected atopic dermatitis at the time of screening.
5. Allergy or sensitivity to any of the ingredients in the study treatment.
6. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallely.
7. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patient-Oriented Eczema Measure (POEM) score documented in the CRF baseline, day 30, day 60 and day 90  baseline, day 30, day 60 and day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Skin Tone, Skin Texture and Moisturisation of Atopic Dermatitis affected areas documented in the CRF baseline, day 30, day 60 and day 90  baseline, day 30, day 60 and day 90 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 4 
Date of First Enrollment (India)   30/12/2020 
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)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dermatitis is also known as eczema, is group of diseases that can results in inflammation of skin. These diseases often characterized by dry, cracked skin, patches of red, scaly, and inflamed skin that may become itchy. There are several types of dermatitis and each type has distinct signs and symptoms. The most common form of dermatitis includes atopic dermatitis, contact dermatitis, dyshidrotic dermatitis, nummular dermatitis, seborrheic dermatitis, and statis dermatitis. Among these, atopic dermatitis (AD) is a most prevalent, and potentially debilitating condition that can affect quality of life (QoL). It is characterized by chronic inflammatory and relapsing pruritic skin lesions that generally begins in early childhood, usually between 3 and 6 months of age. Approximately 15% to 20% of children and 1% to 3% of adults affected worldwide and has 2- to 3-fold of increase in industrialized nations. Incidence of AD was about 28.46% in north Indian children registered to a paediatric dermatology clinic. The clinical features of AD includes pruritic, erythematous, weeping patches on the cheeks, scalp, and extensor surfaces of extremities. These lesions progress to xerosis, thickened plaques, papules, and excoriations on the wrists and flexural surfaces of extremities.
There are a wide variety of pharmacological treatment strategies for prevention and management of dermatitis. But long-term use of pharmacological products results in development of adverse effects. The adverse effects associated with chronic use of current therapeutic agents promoted the use of nutraceuticals or herbal medicines as safety and commercial approaches for the prevention and management of dermatitis. Recently, the nutraceuticals have received substantial attention due to their potential nutritional values, safety, and therapeutic effects. Particularly, their active ingredients can have antioxidant activities and anti-inflammatory effects and have been used in the treatment of many diseases. Therefore, the aim of the current study is to determine the effect of dermatitis lotion for treatment and management of dermatitis. 
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