CTRI

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CTRI Number

CTRI/2012/11/003127 [Registered on: 21/11/2012] Trial Registered Retrospectively

Last Modified On:

19/11/2012

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A clinical trial to study the effects of adapalene, benzoyl peroxide, and benzoyl peroxide-clindamycin combination in patients having pimples.

Scientific Title of Study

A Randomized, open label, active controlled, parallel group trial to compare the safety and efficacy of adapalene, benzoyl peroxide, and benzoyl peroxide-clindamycin combination in patients with acne vulgaris.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Anuradha Dubey
Designation	PG Student
Affiliation	Peoples College of Medical Sciences and Research Centre
Address	Department of Pharmacology, Peoples College of Medical Sciences and Research Centre, Bhanpur, Bhopal Bhopal MADHYA PRADESH 462037 India
Phone	9926193059
Fax
Email	dranudubey999@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Hanmant Amane
Designation	Associate Professr
Affiliation	Peoples College of Medical Sciences and Research Centre
Address	Department of Pharmacology, Peoples College of Medical Sciences and Research Centre, Bhanpur, Bhopal Bhopal MADHYA PRADESH 462037 India
Phone	8717955345
Fax
Email	drhsamane25@gmail.com

Details of Contact Person
Public Query

Name	Dr Hanmant Amane
Designation	Associate Professr
Affiliation	Peoples College of Medical Sciences and Research Centre
Address	Department of Pharmacology, Peoples College of Medical Sciences and Research Centre, Bhanpur, Bhopal Bhopal MADHYA PRADESH 462037 India
Phone	8717955345
Fax
Email	drhsamane25@gmail.com

Source of Monetary or Material Support

Peoples college of medical sciences and research center

Primary Sponsor

Name	Peoples college of medical sciences
Address	Bhanpur Bhopal
Type of Sponsor	Private medical college

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 Hanmant Amane	department of dermatology, PCMS	Bhanpur Bhopal Bhopal MADHYA PRADESH	8717955345 drhsamane25@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Peoples college of medical sciences and research center	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Mild to Moderate Acne vulgaris,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Adapalene	0.1% thin film to be applied once daily at bed time for three months
Comparator Agent	Benzoyl peroxide	2.5% thin film to be applied once daily at bed time for three months
Comparator Agent	Benzoyl peroxide and clindamycin combination	2.5% and 1% thin film to be applied once daily at bed time for three months

Inclusion Criteria

Age From	12.00 Year(s)
Age To	30.00 Year(s)
Gender	Both
Details	1. Healthy males, and non-pregnant females, aged 12-30 years with a clinical diagnosis of mild-moderate acne vulgaris. 2. Presence of Non-inflammatory lesions (comedones). 3. Presence of mild to moderate inflammatory lesions like papules and pustules (Grades 1 and 2).

ExclusionCriteria

Details

1. Acne patients with ages below 12years, or above 30 years.
2. Pregnant and nursing females.
3. Presence of severe inflammatory lesions of acne like nodulo-cystic lesions (Grades 3 and 4).
4. Presence of any other skin condition that would interfere with the diagnosis and assessment of acne vulgaris, (eg-on the face-rosaceae, dermatitis).
5. Excessive facial hair (eg-beard) that would interfere with diagnosis or assessment of acne vulgaris.
6. History of hypersensitivity or allergy to these drugs.
7. Use of any other drug for the treatment of acne vulgaris within 2 months.
8. Patients on hormonal treatment.
9. Patient on drugs causing acne as a side effect.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Acne severity index Total acne lesion count	Acne severity index and Total acne lesion count will be assessed after 2 4 6 8 10 12 weeks.

Secondary Outcome

Outcome	TimePoints
Acne severity index Total acne lesion count	12 weeks

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
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

Phase 4

Date of First Enrollment (India)

15/11/2012

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Not Applicable

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

The present study is a randomized, open label, active controlled, parallel group trial comparing the efficacy and safety of Adapalene 0.1% , Benzoyl peroxide 2.5%, and Benzoyl peroxide 2.5% -Clindamycin 1% combination daily at bed time for 3 months in 150 patients of acne vulgaris. The study will be conducted in Peoples college of medical sciences and research center, Bhopal, India. The primary outcome measures are acne severity index and total acne lesion count.