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

A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01174030

Enrollment

269

Registered

2010-08-03

Start date

2010-08-31

Completion date

2011-01-31

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Brief summary

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

Interventions

DRUGCD07805/47 Gel

CD07805/47 Gel 0.5% QD

DRUGVehicle Gel

Vehicle Gel QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, who is at least 18 years of age or older. * A clinical diagnosis of rosacea. * A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1. * A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1. * A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion criteria

* Three (3) or more facial inflammatory lesions. * Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression. * Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate. * Intraocular pressure (IOP) measurement less than 10 mm Hg.

Design outcomes

Primary

Measure	Time frame	Description
Composite Success	Day 29	Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

Secondary

Measure	Time frame	Description
CEA Success	Day 29	CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Amost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness
PSA-5 Success	day 29	Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness 1. / Very mild redness 2. / Mild redness 3. / Moderate redness 4. / Severe redness

Countries

United States

Participant flow

Participants by arm

Arm	Count
CD07805/47 Gel 0.5% QD	53
CD07805/47 Gel 0.18% QD	54
CD07805/47 Gel 0.18% BID	54
Vehicle Gel QD	55
Vehicle Gel BID	53
Total	269

Baseline characteristics

Characteristic	CD07805/47 Gel 0.18% QD	CD07805/47 Gel 0.18% BID	Vehicle Gel QD	CD07805/47 Gel 0.5% QD	Vehicle Gel BID	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4 Participants	4 Participants	1 Participants	1 Participants	2 Participants	12 Participants
Age, Categorical Between 18 and 65 years	50 Participants	50 Participants	54 Participants	52 Participants	51 Participants	257 Participants
Age, Continuous	46.9 years STANDARD_DEVIATION 12.72	43.2 years STANDARD_DEVIATION 12.28	43.4 years STANDARD_DEVIATION 12.73	44.9 years STANDARD_DEVIATION 11.5	43.0 years STANDARD_DEVIATION 12.33	44.3 years STANDARD_DEVIATION 12.32
Region of Enrollment United States	54 participants	54 participants	55 participants	53 participants	53 participants	269 participants
Sex: Female, Male Female	44 Participants	42 Participants	45 Participants	42 Participants	44 Participants	217 Participants
Sex: Female, Male Male	10 Participants	12 Participants	10 Participants	11 Participants	9 Participants	52 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	18 / 53	13 / 54	14 / 54	16 / 55	8 / 53
serious Total, serious adverse events	0 / 53	1 / 54	0 / 54	1 / 55	0 / 53

Outcome results

Primary

Composite Success

Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

Time frame: Day 29

Population: Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.

Arm	Measure	Group	Value (NUMBER)
CD07805/47 Gel 0.5% QD	Composite Success	Day 29/Hour 3	16 participants
CD07805/47 Gel 0.5% QD	Composite Success	Day 29/Hour 6	15 participants
CD07805/47 Gel 0.5% QD	Composite Success	Day 29/Hour 9	17 participants
CD07805/47 Gel 0.5% QD	Composite Success	Day 29/Hour 12	10 participants
CD07805/47 Gel 0.18% QD	Composite Success	Day 29/Hour 3	10 participants
CD07805/47 Gel 0.18% QD	Composite Success	Day 29/Hour 12	5 participants
CD07805/47 Gel 0.18% QD	Composite Success	Day 29/Hour 6	10 participants
CD07805/47 Gel 0.18% QD	Composite Success	Day 29/Hour 9	7 participants
CD07805/47 Gel 0.18% BID	Composite Success	Day 29/Hour 12	8 participants
CD07805/47 Gel 0.18% BID	Composite Success	Day 29/Hour 6	9 participants
CD07805/47 Gel 0.18% BID	Composite Success	Day 29/Hour 9	11 participants
CD07805/47 Gel 0.18% BID	Composite Success	Day 29/Hour 3	10 participants
Vehicle Gel QD	Composite Success	Day 29/Hour 3	2 participants
Vehicle Gel QD	Composite Success	Day 29/Hour 6	4 participants
Vehicle Gel QD	Composite Success	Day 29/Hour 12	2 participants
Vehicle Gel QD	Composite Success	Day 29/Hour 9	2 participants
Vehicle Gel BID	Composite Success	Day 29/Hour 12	9 participants
Vehicle Gel BID	Composite Success	Day 29/Hour 9	10 participants
Vehicle Gel BID	Composite Success	Day 29/Hour 6	7 participants
Vehicle Gel BID	Composite Success	Day 29/Hour 3	4 participants

p-value: <0.00195% CI: [2.637, 26.71]GEE:Logit link function

p-value: 0.54995% CI: [0.586, 2.747]GEE:Logit link function

p-value: 0.02795% CI: [1.097, 12.742]GEE:Logit link function

Secondary

CEA Success

CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Amost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness

Time frame: Day 29

Population: ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.

Arm	Measure	Group	Value (NUMBER)
CD07805/47 Gel 0.5% QD	CEA Success	Day 29/Hour 9	26 participants
CD07805/47 Gel 0.5% QD	CEA Success	Day 29/Hour 3	27 participants
CD07805/47 Gel 0.5% QD	CEA Success	Day 29/Hour 6	23 participants
CD07805/47 Gel 0.5% QD	CEA Success	Day 29/Hour 12	20 participants
CD07805/47 Gel 0.18% QD	CEA Success	Day 29/Hour 6	21 participants
CD07805/47 Gel 0.18% QD	CEA Success	Day 29/Hour 3	21 participants
CD07805/47 Gel 0.18% QD	CEA Success	Day 29/Hour 12	17 participants
CD07805/47 Gel 0.18% QD	CEA Success	Day 29/Hour 9	20 participants
CD07805/47 Gel 0.18% BID	CEA Success	Day 29/Hour 3	22 participants
CD07805/47 Gel 0.18% BID	CEA Success	Day 29/Hour 12	18 participants
CD07805/47 Gel 0.18% BID	CEA Success	Day 29/Hour 6	18 participants
CD07805/47 Gel 0.18% BID	CEA Success	Day 29/Hour 9	23 participants
Vehicle Gel QD	CEA Success	Day 29/Hour 3	12 participants
Vehicle Gel QD	CEA Success	Day 29/Hour 12	12 participants
Vehicle Gel QD	CEA Success	Day 29/Hour 9	12 participants
Vehicle Gel QD	CEA Success	Day 29/Hour 6	12 participants
Vehicle Gel BID	CEA Success	Day 29/Hour 12	16 participants
Vehicle Gel BID	CEA Success	Day 29/Hour 3	9 participants
Vehicle Gel BID	CEA Success	Day 29/Hour 6	12 participants
Vehicle Gel BID	CEA Success	Day 29/Hour 9	15 participants

p-value: 0.00395% CI: [1.388, 5.188]GEE:Logit link Function

p-value: 0.05695% CI: [0.98, 3.651]GEE: Logit link Function

p-value: 0.07495% CI: [0.946, 3.756]GEE:Logit link Function

Secondary

PSA-5 Success

Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness 1. / Very mild redness 2. / Mild redness 3. / Moderate redness 4. / Severe redness

Time frame: day 29

Population: ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.

Arm	Measure	Group	Value (NUMBER)
CD07805/47 Gel 0.5% QD	PSA-5 Success	Day 29/Hour 3	25 participants
CD07805/47 Gel 0.5% QD	PSA-5 Success	Day 29/Hour 6	26 participants
CD07805/47 Gel 0.5% QD	PSA-5 Success	Day 29/Hour 9	22 participants
CD07805/47 Gel 0.5% QD	PSA-5 Success	Day 29/Hour 12	20 participants
CD07805/47 Gel 0.18% QD	PSA-5 Success	Day 29/Hour 3	17 participants
CD07805/47 Gel 0.18% QD	PSA-5 Success	Day 29/Hour 12	9 participants
CD07805/47 Gel 0.18% QD	PSA-5 Success	Day 29/Hour 6	13 participants
CD07805/47 Gel 0.18% QD	PSA-5 Success	Day 29/Hour 9	9 participants
CD07805/47 Gel 0.18% BID	PSA-5 Success	Day 29/Hour 12	16 participants
CD07805/47 Gel 0.18% BID	PSA-5 Success	Day 29/Hour 6	15 participants
CD07805/47 Gel 0.18% BID	PSA-5 Success	Day 29/Hour 9	19 participants
CD07805/47 Gel 0.18% BID	PSA-5 Success	Day 29/Hour 3	20 participants
Vehicle Gel QD	PSA-5 Success	Day 29/Hour 3	7 participants
Vehicle Gel QD	PSA-5 Success	Day 29/Hour 6	8 participants
Vehicle Gel QD	PSA-5 Success	Day 29/Hour 12	5 participants
Vehicle Gel QD	PSA-5 Success	Day 29/Hour 9	5 participants
Vehicle Gel BID	PSA-5 Success	Day 29/Hour 12	10 participants
Vehicle Gel BID	PSA-5 Success	Day 29/Hour 9	13 participants
Vehicle Gel BID	PSA-5 Success	Day 29/Hour 6	11 participants
Vehicle Gel BID	PSA-5 Success	Day 29/Hour 3	11 participants

p-value: <0.00195% CI: [2.755, 15.723]GEE: Logit link function

p-value: 0.09395% CI: [0.903, 3.802]GEE: Logit link function

p-value: 0.05495% CI: [0.96, 5.825]GEE: Logit link function

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Composite Success

CEA Success

PSA-5 Success