Trial Outcomes & Findings for Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea (NCT NCT00823901)

Last Updated: 2012-06-25

Results Overview

The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

83 participants

Primary outcome timeframe

Baseline, week 12

Results posted on

2012-06-25

Participant Flow

Subjects were recruited at MGH and Stanford University Hospital.

Some subjects required a wash-out of medications they were using. Subjects were excluded if they did not have enough lesions.

Participant milestones

Participant milestones
Measure	Clindamycin/Tretinoin Gel Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks	Placebo Gel Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
Overall Study STARTED	43	40
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clindamycin/Tretinoin Gel Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks	Placebo Gel Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clindamycin/Tretinoin Gel n=43 Participants Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks	Placebo Gel n=40 Participants Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=93 Participants	39 Participants n=4 Participants	81 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age Continuous	53.2 years STANDARD_DEVIATION 13.6 • n=93 Participants	51.2 years STANDARD_DEVIATION 14.0 • n=4 Participants	52.17 years STANDARD_DEVIATION 13.74 • n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	31 Participants n=4 Participants	59 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	9 Participants n=4 Participants	24 Participants n=27 Participants
Region of Enrollment United States	43 participants n=93 Participants	40 participants n=4 Participants	83 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, week 12

Population: Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used.

Outcome measures

Outcome measures
Measure	Clindamycin/Tretinoin Gel n=41 Participants Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks	Placebo n=39 Participants Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
Mean Change in Number of Inflammatory Lesions From Baseline to Week 12	.83 lesions Standard Deviation 10.84	-3.13 lesions Standard Deviation 13.28

Adverse Events

Clindamycin/Tretinoin Gel

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo Gel

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clindamycin/Tretinoin Gel n=41 participants at risk；n=43 participants at risk Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks	Placebo Gel n=39 participants at risk；n=40 participants at risk Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
Skin and subcutaneous tissue disorders Worsening rosacea	17.1% 7/41 • Number of events 7 • 12 weeks (duration of study participation)	10.3% 4/39 • Number of events 4 • 12 weeks (duration of study participation)
Skin and subcutaneous tissue disorders Facial scaling	14.6% 6/41 • Number of events 6 • 12 weeks (duration of study participation)	0.00% 0/39 • 12 weeks (duration of study participation)
Skin and subcutaneous tissue disorders Facial Dryness	12.2% 5/41 • Number of events 5 • 12 weeks (duration of study participation)	5.1% 2/39 • Number of events 2 • 12 weeks (duration of study participation)
Skin and subcutaneous tissue disorders Facial redness	9.8% 4/41 • Number of events 4 • 12 weeks (duration of study participation)	5.1% 2/39 • Number of events 2 • 12 weeks (duration of study participation)
Skin and subcutaneous tissue disorders Facial burning sensation	4.9% 2/41 • Number of events 2 • 12 weeks (duration of study participation)	0.00% 0/39 • 12 weeks (duration of study participation)
Skin and subcutaneous tissue disorders Facial itching	7.3% 3/41 • Number of events 3 • 12 weeks (duration of study participation)	5.1% 2/39 • Number of events 2 • 12 weeks (duration of study participation)
Skin and subcutaneous tissue disorders Facial irritation	4.9% 2/41 • Number of events 2 • 12 weeks (duration of study participation)	2.6% 1/39 • Number of events 1 • 12 weeks (duration of study participation)

Additional Information

Alexandra B. Kimball, MD

MGH CURTIS

Phone: 617-726-5066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place