Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01659853
• Collaborator: (none)
• Enrollment: 70
• Locations: 4
• Arm: 1
• Duration (Months): 3
• Patients Per Site: 17.5
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Condition or Disease	Intervention/Treatment	Phase
Erythema; Rosacea	Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle; Drug: azelaic acid gel 15%	Phase 3

Detailed Description

Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Overall Study In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).

Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle; To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily; Other Names: brimonidine tartrate gel 0.5% brimonidine tartrate gel vehicle ; Drug: azelaic acid gel 15%; During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily; Other Names: Finacea® gel 15%

Outcome Measures

Primary Outcome Measures

1. Composite Success [Hour 6 on Day 15]

   Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period

Secondary Outcome Measures

1. Onset of Action [30 minutes after baseline treatment application on Day 15]

   Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is male or female aged 18 years or older.

2. Subject has a clinical diagnosis of facial rosacea.

3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.

4. Subject has a self assessment score of moderate to severe redness prior to enrollment.

5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.

2. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.

3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.

4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.

5. Subjects with known allergies or sensitivities to one of the components of the investigational products.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hudson Dermatology	Evansville	Indiana	United States	47714
2	Dermatology Specialists Research, LLC	Louisville	Kentucky	United States	40202
3	DermResearch, Inc	Austin	Texas	United States	78759
4	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W. Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01659853
• Other Study ID Numbers: US10219
• First Posted: Aug 8, 2012
• Last Update Posted: Aug 25, 2022
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Rosacea; Erythema; Azelaic acid; Brimonidine Tartrate

Study Results

Participant Flow

Arm/Group Title	CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%	Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle
Arm/Group Description	Subjects were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.	Subjects were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
Period Title: Treatment Period 1
STARTED	35	35
COMPLETED	35	35
NOT COMPLETED	0	0
Period Title: Treatment Period 1
STARTED	35	35
COMPLETED	33	35
NOT COMPLETED	2	0
Period Title: Treatment Period 1
STARTED	33	35
COMPLETED	33	35
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Participants were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
Overall Participants	70
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	62 88.6%
>=65 years	8 11.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.4 (10.9)
Sex: Female, Male (Count of Participants)
Female	52 74.3%
Male	18 25.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.4%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	69 98.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	70 100%
Fitzpatrick skin type (participants) [Number]
I	6 8.6%
II	35 50%
III	24 34.3%
IV	4 5.7%
V	1 1.4%
VI	0 0%
Skin type (participants) [Number]
Dry	14 20%
Normal	33 47.1%
Oily	6 8.6%
Combination	17 24.3%

Outcome Measures

1. Primary Outcome

Title	Composite Success
Description	Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Time Frame	Hour 6 on Day 15

Outcome Measure Data

Analysis Population Description

A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.

Arm/Group Title	CD07805/47 Gel 0.5% and Vehicle	Azelaic Acid Gel 15%
Arm/Group Description	Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1. A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.	Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1. A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
Measure Participants	35	35
Number [percentage of subjects]	14.3	5.7

2. Secondary Outcome

Title	Onset of Action
Description	Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Time Frame	30 minutes after baseline treatment application on Day 15

Outcome Measure Data

Analysis Population Description

A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.

Arm/Group Title	CD07805/47 Gel 0.5 and Vehicle	Azelaic Acid 15%
Arm/Group Description	Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1. A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.	Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1. A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
Measure Participants	35	35
Number [percentage of subjects]	31.4	29.4

Adverse Events

Time Frame	15 days
Adverse Event Reporting Description	Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
Arm/Group Title	CD07805/47 Gel 0.5 and Vehicle		Azelaic Acid 15%
Arm/Group Description	Participants were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.		Participants were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
All Cause Mortality
	CD07805/47 Gel 0.5 and Vehicle		Azelaic Acid 15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CD07805/47 Gel 0.5 and Vehicle		Azelaic Acid 15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	CD07805/47 Gel 0.5 and Vehicle		Azelaic Acid 15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/70 (27.1%)		27/68 (39.7%)
General disorders
Medication residue	0/70 (0%)	0	9/68 (13.2%)	9
Infections and infestations
Upper respiratory infection	2/70 (2.9%)	2	2/68 (2.9%)	2
Skin and subcutaneous tissue disorders
Erythema	15/70 (21.4%)	20	2/68 (2.9%)	2
Pain of skin	0/70 (0%)	0	6/68 (8.8%)	6
Pruritus	1/70 (1.4%)	1	10/68 (14.7%)	11
Skin burning sensation	1/70 (1.4%)	1	6/68 (8.8%)	6
Skin discomfort	0/70 (0%)	0	2/68 (2.9%)	2

Limitations/Caveats

A significant period effect was observed for CEA indicating there was carryover from period 1 to period 2. Therefore, as stated a priori in the protocol, only data from period 1 were used to analyze efficacy. All safety data are reported.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.