Trial Outcomes & Findings for Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea (NCT NCT00989014)

NCT ID: NCT00989014

Last Updated: 2021-02-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 122 participants
• Primary outcome timeframe: Baseline and every hour for 12 hours following application
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	CD07805/47 0.5% Topical Gel 0.5% Topical Gel	CD07805/47 0.18% Topical Gel 0.18% Topical Gel	CD07805/47 0.07% Topical Gel 0.07% Topical Gel	CD07805/47 Vehicle Topical Gel Vehicle Topical Gel
Overall Study STARTED	31	31	28	32
Overall Study COMPLETED	31	31	28	32
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

Baseline characteristics by cohort

Measure	CD07805/47 0.5% Topical Gel n=31 Participants 0.5% Topical Gel	CD07805/47 0.18% Topical Gel n=31 Participants 0.18% Topical Gel	CD07805/47 0.07% Topical Gel n=28 Participants 0.07% Topical Gel	CD07805/47 Vehicle Topical Gel n=32 Participants Vehicle Topical Gel	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	30 Participants n=7 Participants	27 Participants n=5 Participants	29 Participants n=4 Participants	117 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Age, Continuous	45.8 years STANDARD_DEVIATION 11.87 • n=5 Participants	46.3 years STANDARD_DEVIATION 12.37 • n=7 Participants	43.7 years STANDARD_DEVIATION 10.74 • n=5 Participants	46.7 years STANDARD_DEVIATION 13.35 • n=4 Participants	45.7 years STANDARD_DEVIATION 12.06 • n=21 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	24 Participants n=4 Participants	92 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment United States	31 participants n=5 Participants	31 participants n=7 Participants	28 participants n=5 Participants	32 participants n=4 Participants	122 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and every hour for 12 hours following application

Outcome measures

Measure	CD07805/47 0.5% Topical Gel n=31 Participants 0.5% Topical Gel	CD07805/47 0.18% Topical Gel n=31 Participants 0.18% Topical Gel	CD07805/47 0.07% Topical Gel n=28 Participants 0.07% Topical Gel	CD07805/47 Vehicle Topical Gel n=32 Participants Vehicle Topical Gel
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.	17 participants	10 participants	7 participants	4 participants

Adverse Events

CD07805/47 0.5% Topical Gel

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

CD07805/47 0.18% Topical Gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CD07805/47 0.07% Topical Gel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CD07805/47 Vehicle Topical Gel

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CD07805/47 0.5% Topical Gel n=31 participants at risk 0.5% Topical Gel	CD07805/47 0.18% Topical Gel n=31 participants at risk 0.18% Topical Gel	CD07805/47 0.07% Topical Gel n=28 participants at risk 0.07% Topical Gel	CD07805/47 Vehicle Topical Gel n=32 participants at risk Vehicle Topical Gel
Nervous system disorders Headache	9.7% 3/31	0.00% 0/31	0.00% 0/28	6.2% 2/32
Skin and subcutaneous tissue disorders Skin Irritation	3.2% 1/31	0.00% 0/31	7.1% 2/28	3.1% 1/32
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/31	3.2% 1/31	3.6% 1/28	6.2% 2/32

Additional Information

Michael Graeber, MD

Galderma

Phone: 609-860-8201

Email: michael.graeber@galderma.com

Results disclosure agreements

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

Restriction type: GT60