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CTRI Number  CTRI/2021/10/037244 [Registered on: 11/10/2021] Trial Registered Prospectively
Last Modified On: 09/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin health 
Scientific Title of Study   A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Clinical Trial Assessing the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and amelioration of skin health. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Kumar Prabhu 
Designation  Principal Investigator 
Affiliation  Skin Xperts Unit of BGMF SkinXperts Pvt Ltd 
Address  60/62, 8th Main Jayanagar 4th Block Bangalore, Karnataka 560011 India

Bangalore
KARNATAKA
560094
India 
Phone  9900102030  
Fax    
Email  sunilpr13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Divya C 
Designation  CEO 
Affiliation  Bioagile Therapeutics Pvt. Ltd 
Address  2/5, Dahila Building, 3rd Floor 80 Feet Road, RMV 2nd Stage, Dollars Colony

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  CEO 
Affiliation  Bioagile Therapeutics Pvt. Ltd 
Address  2/5, Dahila Building, 3rd Floor 80 Feet Road, RMV 2nd Stage, Dollars Colony

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Vidya Herbs Pvt Ltd 
 
Primary Sponsor  
Name  Vidya Herbs Pvt Ltd 
Address  Vidya Building, N3-3 24th Main JP Nagar, 1st Phase Bangalore – 560078 Karnataka, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Sunil Kumar Prabhu  Skin Xperts Unit of BGMF SkinXperts Pvt Ltd  Skin Xperts Unit of BGMF SkinXperts Pvt Ltd 60/62 Basement 8th B Main 4th T Block Jayanagar Behind GK Vale Nandhini Hotel Jayanagar Bengaluru - 560041
Bangalore
KARNATAKA 		 9900102030

sunilpr13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LIFELINE ETHICS C0MMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GUGGULCERA  Dose / Concentration – 300 mg Mode and frequency of administration – Oral, twice daily Total Daily Dose: 600 mg Duration of treatment: 12 Weeks  
Intervention  GUGGULCERA  The investigational product is a herbal formulation of Commiphora wightii (guggul) and Amorphophallus konjac extracts. The formulation 100 % natural formulation with characteristic taste and odor. It is a light yellowish brown colored powder in capsule form 
Comparator Agent  N/A  Dose / Concentration – NA Mode and frequency of administration – Oral, twice daily Total Daily Dose: N/A Duration of treatment: 12 Weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Male or female aged 18 – 40 years of age both inclusive in general good health
Must have a definite clinical diagnosis of mild to severe acne vulgaris Grade 2 Grade 3 or Grade 4
on the Investigators Global Assessment IGA of acne severity 1
Must be willing and able to give informed consent and comply with the study procedures
Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence from 30 days prior to study entry to 30 days after the last administration of study drug 
 
ExclusionCriteria 
Details  1. Known conditions that may interfere with the evaluation of acne vulgaris. Such conditions include but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
2. Subjects allergic to herbal products or any component of the study product
3. Subjects who have been treated topical or oral corticosteroids within 14 days prior to baseline
4. History of uncontrolled disease or immune deficient disorder
5. Any feature in the test areas (face) that according to the investigator may influence the results, for example, but not limited to moles, tattoos, scars, irritated skin, scratches, cuts and excess hair
6. Known HIV or Hepatitis B positive or any other immuno-compromised state
7. Female subjects who are pregnant, nursing or planning to become pregnant during study participation
8. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin health  Proportion of subjects in each treatment group achieving success at Week 12, with success defined as IGA score of clear or almost clear and at least a one-point reduction in IGA score compared to Baseline.
Mean percentage change in total acne, inflammatory and non-inflammatory lesion count from baseline to end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of the treatment arm in comparison with placebo on the “The Cardiff acne disability index”
To assess the safety and tolerability of the test product.
To assess the effect of the treatment arm in comparison with placebo through following scale and questionnaire:
Allergan Fine Line Scale
Allergan Skin Roughness Scale
Felix Von Lushan Skin Color Chart
Modified Fitzpatrick Wrinkle Scale
Skin Hydration Scale
Patient Satisfaction Questionnaire
 		 Change in scores on the Cardiff Acne Disability Index scoring from baseline to end of the study
Change in scores on following scale and questionnaire from Baseline to End of Study
Allergan Fine Line Scale
Allergan Skin Roughness Scale
Felix Von Lushan Skin Color Chart
Modified Fitzpatrick Wrinkle Scale
Skin Hydration Scale
Patient Satisfaction Questionnaire
Change in laboratory parameters (safety) from baseline to end of the study 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   11/10/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Acne vulgaris is a disorder of the pilosebaceous gland occurring usually at puberty but can also be seen in adult age.[1] The disease characterized by the formation of open and closed comedones (non-inflammatory lesions), papules, pustules, and nodulocystic lesions (inflammatory lesions). The disease generally affects the face, arms, and back. The multifactorial pathogenesis of acne vulgaris includes follicular hyperkeratinization, abnormal sebum production, bacterial proliferation, and inflammation.[2] Acne vulgaris has been divided into four grades – 1, 2, 3, and 4. Grade 1 consists of comedones and occasional papules. Grade 2 consists of papules, comedones and few pustules. Grade 3 consists of predominant pustules, nodules, and abscesses. Grade 4 consists of mainly cysts, abscesses, and widespread scarring.[3] The aims of treatment are to control inflammation, decrease the activity of the sebaceous glands, normalize follicular proliferation, and decrease bacterial colonization. Drugs used for Grades 1 and 2 (mild-to-moderate case) of acne vulgaris are topical comedolytics, antibacterial, and retinoids as monotherapy or combination therapy. Grades 3 and 4 (severe cases) of acne vulgaris require systemic antibacterial along with topical agents.[4]

 
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