| CTRI Number |
CTRI/2018/09/015735 [Registered on: 17/09/2018] Trial Registered Prospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy of Investigational product for the percentage reduction of lesions in patients with Acne vulgaris |
|
Scientific Title of Study
|
A randomized, single blind, parallel group, controlled clinical study to evaluate the efficacy of investigational product versus 0.1% adapelene in patients with acne vulgaris |
| Trial Acronym |
ACNE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BAIG-CSP-010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madan Mohan |
| Designation |
Dermatologist |
| Affiliation |
Dr. B. R. Ambedkar Medical College |
| Address |
OPD Block, 1st Floor,
Dermatology department,
kadugondanahalli,
Bengaluru,
Karnataka - 560045,
India
OPD Block, 1st Floor,
Dermatology department,
kadugondanahalli,
Bengaluru,
Karnataka - 560045,
India
Bangalore
KARNATAKA
560045
India |
| Phone |
9845074316 |
| Fax |
|
| Email |
madanmohan1869@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Dayananda |
| Designation |
General Manager |
| Affiliation |
BioAgile Therapeutics Pvt. Ltd. |
| Address |
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
NA
Bangalore
KARNATAKA
560094
India
Bangalore
KARNATAKA
560094
India |
| Phone |
9980107723 |
| Fax |
|
| Email |
pm@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
Director |
| Affiliation |
BioAgile Therapeutics Pvt. Ltd. |
| Address |
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
NA
Bangalore
KARNATAKA
560094
India
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Atrimed Pharmaceuticals Pvt Ltd |
| Address |
No 29-30, Prestige Meridian
14th floor, Tower 2,
MG Road, Bengaluru – 560001, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madan Mohan |
Dr. B. R. Ambedkar Medical College |
OPD Block, 1st Floor,
Dermatolofy department,
Kadugondanahalli,
Bengaluru,
Karnataka - 560045
India
Bangalore
KARNATAKA |
9845074316
madanmohan1869@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. B. R. Ambedkar Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Acne vulgaris |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.1% Adapelene |
0.1% Adapelene for topical application intended for the treatment of acne vulgaris.
To be applied twice daily for 15days |
| Intervention |
20 gm tube |
The Investigational Test Product is a formulation for topical application suitable for the treatment and management of Acne. This formulation contain Ficus Benghalensis, Acorus calamus, Ocimum sanctum, presented as cream.
to applied twice daily for 15days |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 11 yrs. and 30 yrs.
2. Both genders
3. Patients with inflammatory and non-inflammatory papules, open and closed comedones with few pustules present over the skin.
4. AGSS score more than 1
5. Count lesion of more than 10
6. Lesion to be present for not less than 3 months (recurrent lesions are included)
7. Able to give informed consent. For patients younger than 18 years old, representatives (parents/guardians) are required to provide informed consent and the same will be documented.
|
|
| ExclusionCriteria |
| Details |
1. Subjects on any other medication or cosmetics
2. Subjects using other anti-acne medications in the last 30 days before study
3. Patients with history of allergy to topical antibiotics
4. Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period
5. Patients who had participated in other clinical studies within 3 months of the start of the study
6. Subjects who have any clinically significant allergic disease at the time of first examination or unwilling to enter into the study because of recent drug allergy.
7. History or presence of any debilitating disease like cancer, RA, TB etc.
8. Patients on OCP, antibiotics.
9. Patients with cystic acne and acne rosacea.
10. Patients on MAOI, ant- epileptics treatment, lithium.
11. PCOD / Underlying endocrine disease.
12. Patients with nodulocystic acne and acne fulminans.
13. Patients on steroids and ATT.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the changes will be assessed compared to the baselines values with respect to reduction in number and severity of inflammatory/non inflammatory lesions. |
Day 0, Day 7 and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
17/09/2018 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acne is a chronic disease of sebaceous follicles that is multifactorial in etiology. It can wax and wane in severity according to lesion types, numbers, and extent of involvement and can result in scarring. Acne occurs more frequently on the face, but can also occur on the non-facial skin (e.g., trunk). There are two major types of acne lesions: 1. Non-inflammatory: Non-inflammatory lesions are the open (blackheads) or closed (whiteheads) comedones. 2. Inflammatory: Inflammatory lesions include papules, pustules, and nodules. Although most drug products for acne are intended for the broad indication of acne vulgaris, some drug products have been developed that only target one of these two lesion subsets. Acne is primarily a disease of adolescence and young adulthood but can persist past the third decade of life. Numerous topical and systemic drugs have been developed in the past years and most, if not all, are available in India. The challenge is to meet the rising expectations of the youth of India, who make up the bulk of acne population and will demand the best. For successful treatment of acne, new formulations in combination therapy have been developed. These formulations will not only increase the efficacy of the treatment but also boost the adherence. Furthermore, they minimize the resistance. |