| CTRI Number |
CTRI/2018/10/016050 [Registered on: 16/10/2018] Trial Registered Prospectively |
| Last Modified On: |
09/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Herbal Acne-Pro Gel in treatment of acne |
|
Scientific Title of Study
|
A randomized, controlled, comparative study to assess the efficacy and safety of Acne-Pro Gel in treatment of acne |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shihiji Srivastava |
| Designation |
Cosmetic Phycian |
| Affiliation |
Elite Aesthetic and Cosmetic Clinic |
| Address |
E 311 Greater Kailash -2
South
DELHI
110048
India |
| Phone |
9205340090 |
| Fax |
|
| Email |
drelite27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Singh |
| Designation |
Head Clinical Operation |
| Affiliation |
Clinical Research Network India |
| Address |
Inox Tower, New Bridge Centre, Sector 16A Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
nidhiray46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Singh |
| Designation |
Head Clinical Operation |
| Affiliation |
Clinical Research Network India |
| Address |
Inox Tower, New Bridge Centre, Sector 16A Noida
UTTAR PRADESH
201301
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
nidhiray46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India |
|
|
Primary Sponsor
|
| Name |
Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India |
| Address |
A-89 Amritpuri (opp. Iskcon Temple) East of Kailash, New Delhi-110065 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 Shihiji Srivastava |
Elite Aesthetic & Cosmetic Clinic |
E 311 Greater Kailash -2
South
DELHI |
9205340090
drelite27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, (2) ICD-10 Condition: L700||Acne vulgaris, (3) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acne-Pro gel |
The test product Acne Pro is gel predominantly consisting of a unique blend Tea tree, Jojoba, Evening Primrose oils, Aloe Vera Gel
Application for 1 month duration.
A pinch of the gel needs to be applied twice daily. |
| Comparator Agent |
Clindamycin gel 1% |
The comparator Clindamycin gel is to be applied, as directed, twice a day to the affected skin in a thin layer for 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must be adults, aged 18-45 years old with mild to moderate facial acne with 10-100 lesions.
2. Should have an acne grade of at least 2.
3. Females Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
4. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
5. Participants must be willing to apply the test product and return for assessment visits for evaluation.
6. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications treatment that has not been recommended by the study physician.
7. Participants must agree to take healthy diet and life style.
|
|
| ExclusionCriteria |
| Details |
1. Participants with more than 2 acne nodules.
2. Single or married subjects who are pregnant or have borne children in past one year.
3. Participants with a current skin disease other than acne.
4. Participants with facial hair that may obscure acne lesions.
5. Participant with a history of Use of topical or systemic steroids OR topical or systemic antibiotics within the last 2 or 4 weeks, respectively; Use of topical acne treatments (eg. benzoyl peroxide, salicylates, retinoids) within the last 2 weeks OR Use of systemic retinoids within the past 6 months
6. Participant undergone procedures on the face such as peels, laser therapy or microdermabrasion within the past 4 weeks
7. Women of childbearing potential not using a reliable contraceptive method. Participants taking oral contraceptives must have been taking their current contraceptive for the previous 3 months and must agree to continue with it until study completion. Concurrent diseases which exclude the administration of therapy as outlined by the study protocol
8. Participant with a evidence of concurrent disease that exclude administration of therapy as outlined by the study protocol.
9. Participant with history or presence of Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration.
10. Subjects who, in the opinion of the investigator, abuse alcohol or drugs
4. Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician.
5. Participant with known allergies to the main components of the test or comparator product.
6. Participation in another clinical trial or taking an investigational product in the past three months
7. Any participant who is not able to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary endpoints comprise of various criteria measured for defining efficacy of the treatment. Criteria for efficacy are:
1. Decrease in non-inflammatory lesion count from the baseline.
2. Decrease in inflammatory lesion count from the baseline.
3. Decrease in perceived facial oiliness.
|
Baseline Visit
(Day 0) Assessment Visit 1
(Day 7 ±2 days) Assessment Visit 2
(Day 15 ±2 days) Assessment Visit 3
(Day 30 ±2 days)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary endpoints comprise of the safety analyses
Mean tolerability score Evaluated as the average of the following Parameters: Erythema, scaling, peeling, burning, induration and dryness scored using a 5-point scale (0 None, 1 Minimal, 2 Mild, 3 Moderate, 4 Severe)
Local or systemic adverse events will be recorded including type of reaction and severity using a 5 point scale where 0 none and 4 severe.
|
Day 0, Day 7, Day 15 and Day 30 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/11/2018 |
| 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="1"
Months="2"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be done as per Sponsor requirement after study completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Eligible participants screened in baseline
interview will be randomized into two groups to be treated with either the test
product Acne-Pro or comparator. The
baseline interview will collect demographic data and history of acne such as
number of inflamed and non-inflamed facial lesions will be recorded. Level of
acne will be graded using a 5-point severity scale (0-4; 0 = clear skin;
1=almost clear; 2= mild severity with few non inflamed lesions; 3=moderate
severity with many non-inflamed and some inflamed lesions; and 4= severe with
many inflamed lesions).Subjects will be evaluated at Day 7, Day 15 and at the
end of one month (Day 30) (assessment visits) subsequent to the initiation of
treatment. Safety analyses will be done at each visit.
|