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Trial registered on ANZCTR


Registration number
ACTRN12612001006831
Ethics application status
Approved
Date submitted
17/09/2012
Date registered
18/09/2012
Date last updated
17/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the efficacy and safety of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris; a clinical trial
Scientific title
A randomized, double-blind, clinical trial to compare the efficacy (lesion number), side effects, and patient's satisfaction rate of topical adapalene and benzoyl peroxide in the cases with mild acne vulgaris
Secondary ID [1] 281241 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne vulgaris 287433 0
Condition category
Condition code
Skin 287769 287769 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients received topical adapalene 0.1% gel (ADA; Differin; Galderma, Watford, UK) once daily for 8 weeks.
Intervention code [1] 285708 0
Treatment: Drugs
Comparator / control treatment
Patients received topical BPO 2.5% gel (Benzac AC; Galderma, Watford, UK) once daily for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287998 0
Number of facial acne lesions: For this purpose, the open and closed comedones (noninflammatory lesions), as well as the pustules, papules, and nodules (inflammatory lesions) were counted on the forehead, cheeks, nose, and chin by a single investigator under appropriate magnification.
Timepoint [1] 287998 0
At the first, second and third months posttreatment
Secondary outcome [1] 299233 0
Side effects including facial redness, dryness, and peeling which were reported by an investigator after thorough physical exam; as well as facial itching and burning which were solicited from the patient.
Timepoint [1] 299233 0
At the first, second and third months posttreatment
Secondary outcome [2] 299266 0
Patient?s overall satisfaction which was inquired and rated as poor, intermediate, good or excellent
Timepoint [2] 299266 0
At the end of the third month posttreatment.

Eligibility
Key inclusion criteria
Diagnosis of acne vulgaris
Mild disease according to the Evaluator Global Severity Score (grade 2)
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe acne vulgaris
Any dermatologic conditions requiring systemic therapy
Nursing/pregnant women
The women were planning for pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4559 0
Iran, Islamic Republic Of
State/province [1] 4559 0

Funding & Sponsors
Funding source category [1] 286020 0
Self funded/Unfunded
Name [1] 286020 0
Dr Rohollah F Fouladi
Address [1] 286020 0
Azadi Ave., Hafe Square, Sina Hospital, Department of Dermatology, East Azerbayjan, Tabriz, PO BOX: 5163639888
Country [1] 286020 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Dr Shahla Talghini
Address
Azadi Ave., Hafe Square, Sina Hospital, Department of Dermatology, East Azerbayjan, Tabriz, PO BOX: 5163639888
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 284836 0
Individual
Name [1] 284836 0
Dr Rohollah F Fouladi
Address [1] 284836 0
Azadi Ave., Hafe Square, Sina Hospital, Department of Dermatology, East Azerbayjan, Tabriz, PO BOX: 5163639888
Country [1] 284836 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The present clinical trial aims to compare the efficacy and safety profile of topical adapalene 0.1% and BPO 2.5% gels in patients with mild acne vulgaris.
For this purpose, 60 patients equally received either topical adapalene 0.1% gel or topical BPO 2.5% gel once daily to the entire face (except periocular area and lip) for two consecutive months.
Three months later, number of lesions, side effects and patients' satisfaction were compared between the two groups.
Trial website
Trial related presentations / publications
Babaeinejad SH, Fouladi RF. The efficacy, safety and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris; a randomized trial. J Drugs Dermatol. 2013 Sep 1;12(9):1033-8.
Public notes

Contacts
Principal investigator
Name 34719 0
Dr Rohollah Fadaei Fouladi
Address 34719 0
Azadi Ave., Hafe Square, Sina Hospital, Department of Dermatology, East Azerbayjan, Tabriz, PO BOX: 5163639888
Country 34719 0
Iran, Islamic Republic Of
Phone 34719 0
+989144122542
Fax 34719 0
Email 34719 0
medicorelax@yahoo.com
Contact person for public queries
Name 17966 0
Dr Rohollah F Fouladi
Address 17966 0
Azadi Ave., Hafe Square, Sina Hospital, Department of Dermatology, East Azerbayjan, Tabriz, PO BOX: 5163639888
Country 17966 0
Iran, Islamic Republic Of
Phone 17966 0
+989144122542
Fax 17966 0
Email 17966 0
medicorelax@yahoo.com
Contact person for scientific queries
Name 8894 0
Dr Rohollah F Fouladi
Address 8894 0
Azadi Ave., Hafe Square, Sina Hospital, Department of Dermatology, East Azerbayjan, Tabriz, PO BOX: 5163639888
Country 8894 0
Iran, Islamic Republic Of
Phone 8894 0
+989144122542
Fax 8894 0
Email 8894 0
medicorelax@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary