| CTRI Number |
CTRI/2011/05/001721 [Registered on: 09/05/2011] Trial Registered Prospectively |
| Last Modified On: |
26/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EVALUATION AND COMPARISON OF ANTI-ACNE TEST PRODUCTS ON MILD TO MODERATE ACNE |
|
Scientific Title of Study
|
EVALUATION AND COMPARISON OF ANTI-ACNE TEST PRODUCTS ON MILD TO MODERATE ACNE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/039/0111/STU |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
C.L.A.I.M.S. Pvt. Ltd.
4th Floor, B wing, Modi House
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
4th Floor, B wing, Modi House
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
C.L.A.I.M.S. Pvt. Ltd.
4th Floor, B wing, Modi House
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
4th Floor, B wing, Modi House
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Madhavan S |
| Designation |
Vice President, Clinical Operations |
| Affiliation |
|
| Address |
Apex Laboratories Pvt. Ltd. SIDCO Garment Complex, III Floor, Guindy, Chennai, Tamil Nadu
Apex Laboratories Pvt. Ltd. SIDCO Garment Complex, III Floor, Guindy, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600 032
India |
| Phone |
44-4222-5000 |
| Fax |
44-4222-5005 |
| Email |
operations@apexlab.com |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
Apex Laboratories Pvt. Ltd.SIDCO Garment Complex, III Floor, Guindy, Chennai, Tamil Nadu - 600 032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajiv Joshi |
C.L.A.I.M.S. Pvt. Ltd. |
C.L.A.I.M.S. Pvt. Ltd.
4th Floor, B wing, Modi House,
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W),
Mumbai-400058,
India.
Mumbai
MAHARASHTRA |
66758851
66758854
rsjdr@rediffmail.com |
| Dr Suneel Vartak |
Skin Clinic |
Skin Clinic,
18 Dehabanu Complex,
Near Bytco Point,
Nasik Road – 422101
Tel: 2466268
Nashik
MAHARASHTRA |
2466268
suneel.vartak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With inflammatory acne lesions on entire face. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Sofinox Cream - Sodium Fusidate I.P. equivalent to Fusidic Acid I.P 2%w/w and Ageless gel
Adapalene 0.1% w/w
|
Apply ½ Finger Tip Unit – 1 Finger Tip Unit of Sofinox Cream on the affected area without massaging, after cleansing the area. Apply once a day, morning after bath.
Also,apply ½ Finger Tip Unit – 1 Finger Tip Unit of Ageless Gel on the affected area without massaging, after cleansing the area.
Apply once at night before going to bed. Keep the product (Ageless Gel) for 30 minutes and wash off.
Duration - 12 weeks daily application
|
| Comparator Agent |
• Clindapex Gel
Clindamycin Phosphate USP equivalent to Clindamycin 1% w/w
and Ageless gel
Adapalene 0.1% w/w
|
Apply ½ Finger Tip Unit – 1 Finger Tip Unit of Clindapex Gel on the affected area without massaging, after cleansing the area.
Apply once a day, morning after bath.
Also, apply ½ Finger Tip Unit – 1 Finger Tip Unit of Ageless Gel on the affected area without massaging, after cleansing the area.
Apply once at night before going to bed. Keep the product (Ageless Gel) for 30 minutes and wash off.
Duration - 12 weeks daily application |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men/women with inflammatory acne lesions (5 - 25) on entire face.
2. Age between 18 – 55 yr
3. No treatment for acne in the past 1 month
4. Phototype III and IV.
5. All skin types (greasy, normal) except sensitive skin.
6. Accepting not to use products with the same end benefit during the entire study duration.
7. For whom the Investigator considers that the compliance will be correct.
8. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
9. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women (as confirmed by UPT) and lactating women.
2. History suggestive of any hormonal problems.
3. History of allergic dermatitis or contact allergy to cosmetics,
4. Subjects on oral retinoid in the past 3 months.
5. Hypersensitivity to any cosmetic product, raw material.
6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
8. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of inflammatory acne count. |
Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological evaluation of cutaneous tolerance. |
Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks). |
|
Target Sample Size
Modification(s)
|
Total Sample Size="91"
Sample Size from India="91"
Final Enrollment numbers achieved (Total)= "91"
Final Enrollment numbers achieved (India)="91" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2011 |
| Date of Study Completion (India) |
25/10/2011 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial has been started . This
is a test under dermatological control, multicentric, double blinded,
randomized, comparative – versus initial state, and between groups. At Visit 1, baseline inflammatory acne count and digital photographs were taken. Baseline dermatological scoring was done. Dermatological
evaluation for cutaneous tolerance was done by a Dermatologist.
Inflammatory acne count and digital photographs were taken at all
visits. |