Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000443291
Ethics application status
Not yet submitted
Date submitted
21/05/2009
Date registered
12/06/2009
Date last updated
12/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and Safety Comparison of two different topical gels (one active and one vehicle) in combination with an oral antibiotic in the treatment of Moderate to Severe Acne Vulgaris.
Scientific title
Efficacy and Safety Comparison of Adapalene 0.1%/Benzoyl Peroxide 2.5% gel associated with Lymecycline 300mg Capsules versus Adapalene 0.1%/Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules in the treatment of Moderate to Severe Acne Vulgaris.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne 4830 0
Condition category
Condition code
Skin 237172 237172 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1g of Adapalene 0.1%/Benzoyl Peroxide 2.5% gel will be applied once daily in the evening to the entire face for 12 weeks. One Lymecycline 300mg Capsule will be taken orally in the morning with an adequate amount of fluid for 12 weeks.
Intervention code [1] 4608 0
Treatment: Drugs
Comparator / control treatment
1g of Adapalene 0.1%/Benzoyl Peroxide 2.5% vehicle gel will be applied once daily in the evening to the entire face for 12 weeks. One Lymecycline 300mg Capsule will be taken orally in the morning with an adequate amount of fluid for 12 weeks. The control group will apply vehicle gel (control) once daily in the evening to the entire face for 12 weeks and take one Lymecycline 300mg oral capsule once daily in the morning with an adequate amount of fluid for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 237990 0
Efficacy
Non-Inflammatory Lesion (open and closed
comedones) and Inflammatory Lesion (papules,
pustules, nodules/cysts if present) counts on the face
(excluding the nose) at each study visit,
Investigators Global Assessment: severity of acne on
a scale from 0 (Clear) to 5 (Very severe) at each study
visit
Timepoint [1] 237990 0
Baseline, weeks 2, 4, 8 and 12
Secondary outcome [1] 242121 0
Safety
Local tolerability scores - Erythema, Scaling, Dryness,
Stinging/Burning at each study visit,
Recording of Adverse Event(s) at each study visit
Timepoint [1] 242121 0
Baseline, weeks 2, 4, 8 and 12

Eligibility
Key inclusion criteria
Male or female Subjects of any race, between the age of 12
and 35 years inclusive, with moderate to severe acne
vulgaris, meeting specific inclusion/exclusion criteria.
Minimum age
12 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with more than 3 nodules or cysts on the face
2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
acne, etc.),
3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study,

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 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4989 0
Commercial sector/Industry
Name [1] 4989 0
Galderma Australia Pty Ltd
Country [1] 4989 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Galderma Australia Pty Ltd
Address
Suite 4, 13B Narabang Way
Belrose NSW 2085
Country
Australia
Secondary sponsor category [1] 4512 0
Commercial sector/Industry
Name [1] 4512 0
Galderma Research and Development
Address [1] 4512 0
Les Templiers, 2400 Route des Colles, BP87 06902 Sophia Antipolis France
Country [1] 4512 0
France

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 7091 0
Ethics committee address [1] 7091 0
Ethics committee country [1] 7091 0
Date submitted for ethics approval [1] 7091 0
03/06/2009
Approval date [1] 7091 0
Ethics approval number [1] 7091 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29629 0
Address 29629 0
Country 29629 0
Phone 29629 0
Fax 29629 0
Email 29629 0
Contact person for public queries
Name 12876 0
George Tiong
Address 12876 0
Galderma Australia
13B Narabang way Belrose 2085 NSW
Country 12876 0
Australia
Phone 12876 0
+61 2 94790600
Fax 12876 0
Email 12876 0
[email protected]
Contact person for scientific queries
Name 3804 0
Elna van der Walt
Address 3804 0
Galderma Australia
13B Narabang way Belrose 2085 NSW
Country 3804 0
Australia
Phone 3804 0
+61 2 94790600
Fax 3804 0
Email 3804 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.