Trial Outcomes & Findings for Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea (NCT NCT01789775)

NCT ID: NCT01789775

Last Updated: 2014-10-20

Results Overview

Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 114 participants
• Primary outcome timeframe: Day 29
• Results posted on: 2014-10-20

Participant Flow

Participant milestones

Measure	CD07805/47 Gel Placebo Placebo Drug: CD07805/47 gel	CD07805/47 Gel Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo
Overall Study STARTED	55	57
Overall Study COMPLETED	53	50
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea

Baseline characteristics by cohort

Measure	CD07805/47 Gel Placebo n=55 Participants Placebo Drug: CD07805/47 gel	CD07805/47 Gel n=57 Participants Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo	Total n=112 Participants Total of all reporting groups
Age, Continuous	44.9 years STANDARD_DEVIATION 12.1 • n=5 Participants	43.2 years STANDARD_DEVIATION 10.8 • n=7 Participants	44.0 years STANDARD_DEVIATION 11.4 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	56 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment France	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Russian Federation	46 participants n=5 Participants	46 participants n=7 Participants	92 participants n=5 Participants
Region of Enrollment Sweden	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

Outcome measures

Measure	CD07805/47 Gel Placebo n=55 Participants Placebo Drug: CD07805/47 gel	CD07805/47 Gel n=57 Participants Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo
Composite Success Assessment (CEA) and Patient Self Assessment(PSA). D29 Hour 3	32 participants	48 participants
Composite Success Assessment (CEA) and Patient Self Assessment(PSA). D29 Hour 5	33 participants	46 participants
Composite Success Assessment (CEA) and Patient Self Assessment(PSA). D29 Hour 7	35 participants	43 participants
Composite Success Assessment (CEA) and Patient Self Assessment(PSA). D29 Hour 9	33 participants	39 participants

SECONDARY outcome

Timeframe: D1

30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.

Outcome measures

Outcome data not reported

Adverse Events

CD07805/47 Gel Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CD07805/47 Gel

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	CD07805/47 Gel Placebo n=55 participants at risk Placebo Drug: CD07805/47 gel	CD07805/47 Gel n=57 participants at risk Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo
Skin and subcutaneous tissue disorders Angiodema	0.00% 0/55	1.8% 1/57

Other adverse events

Measure	CD07805/47 Gel Placebo n=55 participants at risk Placebo Drug: CD07805/47 gel	CD07805/47 Gel n=57 participants at risk Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo
Skin and subcutaneous tissue disorders Erythema	0.00% 0/55	5.3% 3/57
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/55	12.3% 7/57

Additional Information

Galderma CPM

Galderma R&D

Phone: 00 33 4 93 95 70 70

Email: clinicaltrials@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place