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Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris (TEAM)

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ClinicalTrials.gov Identifier: NCT01014689
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : April 5, 2012
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Adapalene/ BPO gel with Lymecycline capsules
Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules
Enrollment 378
Recruitment Details Recruitment period 14/08/2009 to 21/01/2010 Type of location: hospital, private hospital and private practice.
Pre-assignment Details  
Arm/Group Title Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Hide Arm/Group Description Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
Period Title: Overall Study
Started 191 187
Completed 178 174
Not Completed 13 13
Reason Not Completed
Lack of Efficacy             0             1
Adverse Event             3             0
Withdrawal by Subject             5             4
Protocol Violation             1             1
Lost to Follow-up             3             7
Pregnancy             1             0
Arm/Group Title Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline Total
Hide Arm/Group Description Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 191 187 378
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 187 participants 378 participants
<=18 years
113
  59.2%
102
  54.5%
215
  56.9%
Between 18 and 65 years
78
  40.8%
85
  45.5%
163
  43.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 187 participants 378 participants
18.6  (4.7) 19.1  (4.6) 18.9  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 187 participants 378 participants
Female
91
  47.6%
78
  41.7%
169
  44.7%
Male
100
  52.4%
109
  58.3%
209
  55.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 191 participants 187 participants 378 participants
France 26 25 51
Mexico 52 52 104
Brazil 18 17 35
Poland 16 16 32
Belgium 14 13 27
Australia 15 18 33
Germany 18 17 35
Italy 14 14 28
Sweden 18 15 33
1.Primary Outcome
Title Percent Change From Baseline in Total Lesion Count
Hide Description Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat - Last observation carried forward
Arm/Group Title Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Hide Arm/Group Description:
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
Overall Number of Participants Analyzed 191 187
Median (Full Range)
Unit of Measure: percent of change
-74.1
(-100 to 7.7)
-56.8
(-97.8 to 73.2)
2.Secondary Outcome
Title Success Rate on the Investigator’s Global Assessment (IGA) at Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention To treat - Last Observation Carried Forward
Arm/Group Title Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Hide Arm/Group Description:
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
Overall Number of Participants Analyzed 191 187
Measure Type: Number
Unit of Measure: percent of subjects
47.6 33.7
Time Frame 12 weeks.
Adverse Event Reporting Description All clinical medical events, occured after Subject’s consent signed and during the study, whether observed by the Investigator or reported by the Subject and whether or not thought to be product- or study procedure-related were considered adverse events and collected.
 
Arm/Group Title Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Hide Arm/Group Description Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
All-Cause Mortality
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/191 (0.00%)      0/187 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/191 (13.09%)      26/187 (13.90%)    
Infections and infestations     
NASOPHARYNGITIS * 1  14/191 (7.33%)  15 9/187 (4.81%)  10
Nervous system disorders     
HEADACHE * 1  12/191 (6.28%)  19 17/187 (9.09%)  23
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure agreement in full force and effect for a period of 10 years.
Results Point of Contact
Name/Title: Florence Paliargues / CPM
Organization: Galderma
Phone: +33492952957
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01014689     History of Changes
Other Study ID Numbers: RD.03.SPR.29080
First Submitted: November 16, 2009
First Posted: November 17, 2009
Results First Submitted: August 12, 2011
Results First Posted: April 5, 2012
Last Update Posted: April 20, 2012