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CTRI Number  CTRI/2021/09/036277 [Registered on: 07/09/2021] Trial Registered Prospectively
Last Modified On: 01/11/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Soulter Spotless Cream on reducing acne and acne scars 
Scientific Title of Study   An open label, observational clinical study to determine the efficacy of Soulter Spotless Cream on Acne vulgaris and Acne scars 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parikshit Debnath 
Designation  Chief Physician 
Affiliation  Gananath Sen Institute of Ayurvidya and Research 
Address  64 98B 1 Khudiram Bose Sarani Kolkata - 700037

Kolkata
WEST BENGAL
700037
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parikshit Debnath 
Designation  Chief Physician 
Affiliation  Gananath Sen Institute of Ayurvidya and Research 
Address  64 98B 1 Khudiram Bose Sarani Kolkata - 700037
64 98B 1 Khudiram Bose Sarani Kolkata - 700037
Kolkata
WEST BENGAL
700037
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parikshit Debnath 
Designation  Chief Physician 
Affiliation  Gananath Sen Institute of Ayurvidya and Research 
Address  64 98B 1 Khudiram Bose Sarani Kolkata - 700037
64 98B 1 Khudiram Bose Sarani Kolkata - 700037
Kolkata
WEST BENGAL
700037
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Source of Monetary or Material Support  
PHARMADOCS 1005 Matrix Corporate Road, near S G Highway, Prahlad Nagar, Ahmedabad, Gujarat 380051 
 
Primary Sponsor  
Name  PHARMADOCS 
Address  1005 Matrix Corporate Road, near S G Highway, Prahlad Nagar, Ahmedabad, Gujarat 380051 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
MED PHARMA CRO  119, Rajdanga Gold Park Kolkata 700107 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parikshit Debnath  The Ayurveda Clinic and Research Centre  119, Trivarna Sangha, Landmark: Rajdanga Gold Park, Kolkata
Kolkata
WEST BENGAL 		 9836675720

docdebnath84@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethics Committee (Clinical Research) India  Approved 
Independent Ethics Committee (Clinical Research) India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: KSHUDRAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Soulter Spotless Cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Topical ointment applied locally
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects suffering from Acne Vulgaris and/or having acne scars. Participants willing to give written informed consent. Participants are fit and no need any hospital administration. Agree to following instruction of do’s and don’ts in regular daily lifestyle. Subjects willing to perform all study related procedures including the use of study oil, allow the physical and other tests and willing to document symptoms and medication. Subjects/ volunteers/ study participants {and /or legally accepted representative (LAR)} willing to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements.
 
 
ExclusionCriteria 
Details  Participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. Inability to carry out visits for the study. Chronic & acute disorders requiring hospital admission. Known HIV-positive, Hepatitis B or C status. Volunteers/ study participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in skin status w.r.t. acne vulgaris.
Lightens acne scars.

Clinical assessment- 15 days.
Global Acne Grading System (GAGS)- 15 days.
Investigator Global Assessment of acne (IGA)- 15 days.
Cardiff Acne Disability Index (CADI)- 15 days.
Dermatology Life Quality Index (DLQI)- 15 days.
Safety Assessment Scale- 15 days.
Postinflammatory Hyperpigmentation Severity Scale- 15 days.
 		 Clinical assessment- 15 days.
Global Acne Grading System (GAGS)- 15 days.
Investigator Global Assessment of acne (IGA)- 15 days.
Cardiff Acne Disability Index (CADI)- 15 days.
Dermatology Life Quality Index (DLQI)- 15 days.
Safety Assessment Scale- 15 days.
Postinflammatory Hyperpigmentation Severity Scale- 15 days.


 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in quality of life (DLQI).
Adverse Events.

 		 Changes in quality of life - DLQI - 15 days
No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period - 15 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   05/09/2022 
Date of Study Completion (India) 11/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Publication process is going on in Scientific Journal. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Scientific study title: An open label, observational clinical study to determine the efficacy of Soulter Spotless Cream on Acne vulgaris and Acne scars

Principal investigator: Dr. Parikshit Debnath, B.A.M.S, MD (Ay.), M.Phil (Public Health), MIPHA

Source of monetary support: Pharmadocs

Protocol No.: MPCRO/21-22/CT/001

Primary sponsor: Med Pharma CRO

Study co-ordinators and study site:

  1. Mr. Subhajit Chakraborty – Madhyamgram 1
  2. Ms. Monalisa Chakraborty – Madhyamgram 2
  3. Ms. Nisha Srivastava – Dum Dum
  4. Mr. P.K. Basu – Tollygunj
  5. Mr. Partha Pratim Giri - Kasba

Name of ethics committee: Independent Ethics Committee (CR) India, Kolkata

Health condition studied: Acne vulgaris / acne scars (Ayurveda – Yauvanapidika)

Study type: Single arm trial

Intervention: Soulter Spotless Cream

Sl. No.

Name

Scientific Name

Qty. % w/w

Part used

Form of ingredient

Book Reference

Active Ingredients

1

Manjistha

Rubia cordifolia

1

Stem

Oil

API – I, VOL – III

2

Neem Oil

Azadirachta indica

0.5

Seed oil

Oil

API – I, VOL -II

3

Haridra Oil

Curcuma longa

0.5

Rhizome

Oil

API – I, VOL – I

4

Tea tree Oil

Melaleuca leucadendron

1

Oil

Oil

BH.P

5

Nirgundi Oil

Vitex negundo

1

Leaves oil

Oil

API – I, VOL – III

6

Jati (Jasmine) Oil

Jasminum officinale

1

Leaves oil

Oil

API – I, VOL – III

7

Kamala

Nelumbo nucifera

0.5

Flower

Powder

API – I, VOL – II

8

Gulab Oil

Rosa centifolia

1

Flower oil

Oil

API – I, VOL – III

9

Kalonji

Nigella sativa

1

Bark

Powder

API – I, VOL - I

10

Almond Oil

Prunus amygdalus

1

Oil

Oil

BH.P

11

Kumari

Aloe barbadensis

10

Leaves

Powder

API – I, VOL - I

Base and Excipients

12

Glyceryl Monostearate

 

Q.S.

 

Powder

I.P.

13

Cetostearyl alcohol

 

Q.S.

 

Powder

I.P.

14

Cetomacrogol 1000

 

Q.S.

 

Powder

I.P.

15

Propylene glycol

 

Q.S.

 

Liquid

I.P.

16

Stearic acid

 

Q.S.

 

Powder

I.P.

17

Carbopol934

 

Q.S.

 

Powder

I.P.

18

Glycerin

 

Q.S.

 

Liquid

I.P.

19

Triethanolamine

 

Q.S.

 

Liquid

I.P.

Preservative

20

Sodium benzoate

 

Q.S.

 

Powder

I.P.

Primary outcome: Improvement in skin status w.r.t. acne vulgaris and lightening of acne scars

  • Clinical assessment
  • Global Acne Grading System (GAGS)
  • Investigator Global Assessment of acne (IGA)
  • Cardiff Acne Disability Index (CADI)
  • Dermatology Life Quality Index (DLQI)
  • Safety Assessment Scale
  • Postinflammatory Hyperpigmentation Severity Scale
  • Photographs

Secondary outcome: Percentage change in lesion counts for the secondary endpoint analysis. The baseline data of the evaluating parameters will be compared with the results obtained by the end of the study (15 days). No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period.

Target sample size: 80 participants

Phase of trial: Post Marketing Surveillance

Study plan: An open label observational clinical study will be undertaken under investigator and his teams in Kolkata. Total no. of volunteers/study participants: 80 + 10 % Dropouts. Participants of both sexes aged 13 – 60 and only those volunteers providing written informed consent will be enrolled for the study (without any history or present illness of COVID 19) in specific study centre under the investigator. After receiving the written consent, all participants will be assessed by physical examination. After screening for acne vulgaris and/or acne scars, participants will be enrolled. Study materials will be provided to them free of cost for their regular use, along with specific information. Participants need to apply locally Soulter Spotless Cream regularly for 15 days, 2 times a day. Diet habit/ life style modification will also be guided (do’s and don’ts). The participants will visit their specific centre (s) at baseline and at end of the study for clinical assessment along with questionnaires. Investigator will strictly follow the SOP for the study.

 
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