| CTRI Number |
CTRI/2018/04/013109 [Registered on: 09/04/2018] Trial Registered Prospectively |
| Last Modified On: |
12/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness and safety of a fixed dosed combination of adapalene and clindamycin in the treatment of acne vulgaris. |
|
Scientific Title of Study
|
Comparison of the effectiveness and safety of two topical delivery systems of a fixed dosed combination of adapalene and clindamycin in the treatment of acne vulgaris, a double arm, open label, observational study |
| Trial Acronym |
Adapalene 0.1 % and clindamycin 1 % combination |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrilata S Trasi |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
5th Floor, Gupte House,
S.V Road, Khar(West),
Mumbai, Maharashtra 400052, India.
Mumbai
MAHARASHTRA
400052
India |
| Phone |
9820124715 |
| Fax |
|
| Email |
shrilata_trasi@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrilata S Trasi |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
5th Floor, Gupte House,
S.V Road, Khar(West),
Mumbai, Maharashtra 400052, India.
Mob-9820124715
Mumbai
MAHARASHTRA
400052
India |
| Phone |
022-26051858 |
| Fax |
|
| Email |
shrilata_trasi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrilata S Trasi |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
5th Floor, Gupte House,
S.V Road, Khar(West),
Mumbai, Maharashtra 400052, India.
Mumbai
MAHARASHTRA
400052
India |
| Phone |
9820124715 |
| Fax |
|
| Email |
shrilata_trasi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator Initiated Study |
|
|
Primary Sponsor
|
| Name |
Investigator Initiated Study |
| Address |
5th Floor, Gupte House,
S.V Road, Khar(West),
Mumbai, Maharashtra 400052, India. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shrilata S Trasi |
DR. TRASI’S CLINIC |
5th Floor, Gupte House,
S.V Road, Khar (west),
Mumbai, Maharashtra 400052, INDIA.
Mumbai
MAHARASHTRA |
9820124715
022-26051858
shrilata_trasi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acne Vulgaris, (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with acne of mild to moderate as per the Combined Acne Severity Classification.8
a. Mild acne: fewer than 20 comedones, or fewer than 15 inflammatory lesions or a total lesion count lower than 30
b. Moderate acne: 20-100 comedones, or 15-50 inflammatory lesions or a total lesion count of 30-125
c. Severe acne: more than 5 cysts, or comedone count greater than 100, or a total inflammatory count greater than 50, or a total lesion count greater than 125
2. Male and female patients aged between 18 to 30 years.
3. Subjects willing to comply with study visits and procedure
4. Patients taking certain topical and systemic treatments required to undergo 01 month washout periods before they can enter the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to sign consent form
2. Who have a diagnosed hormonal or endocrine cause for acne
3. Acne conglobata, acne fulminans, secondary acne, severe acne, or other dermatologic conditions requiring systemic treatment.
4. Women are to be excluded if they are pregnant, planning a pregnancy or nursing
5. Patients having any contraindication to clindamycin or adapalene
6. Men with beards are excluded if these are likely to cause interference with study assessments
7. Any significant medical condition which may interfere with the patients optimal participation in the study as per Investigators opinion |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of hydro swelling polymer delivery system with microsphere delivery system of a combination of adapalene 0.1% + clindamycin 1% in patients with acne. |
day 0, day 28, day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of hydro swelling polymer delivery system with microsphere delivery system of a combination of adapalene 0.1% & clindamycin 1% in patients with acne |
Day 0, day 28, Day 56 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Topical combination of adapalene and clindamycin is used
routinely in the management of acne. Adapalene is associated with adverse
effects such as redness and drying of the skin and hence, controlled delivery
systems are clinically useful in reducing these. Polymer technology consists of
hydro-swelling droplets which imbibe adapalene and clindamycin and release it
slowly. Microspheres are a different technology consisting of inert, porous,
spherical microparticles designed to entrap active ingredient. We aim to
compare these technologies in their effectiveness and safety. |