Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01872715
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: Oracea	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oracea Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks	Drug: Oracea; Other Names: doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)

Outcome Measures

Primary Outcome Measures

1. Rosacea Score on the Visual Analog Scale [Baseline, Weeks 2, 6, and 12]

   VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable

Secondary Outcome Measures

1. Rosacea-Specific Quality of Life Index [Baseline, Weeks 2, 6, and 12]

   ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)

2. Patient Global Assessment (PGA) of Rosacea Scores [Baseline, Weeks 2, 6, and 12]

   Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules

3. Patient Satisfaction Question [Week 2, 6, and 12]

   The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men and women

• 25-70 years

• Diagnosis of papulopustular rosacea

• Eligible for Oracea treatment

Exclusion Criteria:

• Allergies to components of investigational product and/or hypersensitivity to tetracyclines

• Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit

• Used topical rosacea treatment within 30 days prior to baseline visit

• Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist

• Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics

• Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study

• Have planned surgical procedures during the course of the study

• Have used tetracycline antibiotics within 30 days prior to baseline visit or during study

• At risk in terms of precautions, warnings, and contraindications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephens & Associates Dallas Research Center	Carrollton	Texas	United States	75006

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01872715
• Other Study ID Numbers: GLI.04.SPR.US10233
• First Posted: Jun 7, 2013
• Last Update Posted: Aug 23, 2022
• Last Verified: Jan 1, 2016

• Keywords provided by Galderma R&D: Papulopustular Rosacea; Oracea; anti inflammatory doxycycline
• Additional relevant MeSH terms: Rosacea; Doxycycline

Study Results

Participant Flow

Arm/Group Title	Oracea
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea
Period Title: Overall Study
STARTED	24
COMPLETED	20
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Oracea
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea
Overall Participants	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.04 (11.02)
Sex: Female, Male (Count of Participants)
Female	1 4.2%
Male	23 95.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 12.5%
Not Hispanic or Latino	21 87.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	24 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Years since the first rosacea diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.75 (8.36)
Skin type (participants) [Number]
Dry	8 33.3%
Normal	4 16.7%
Oily	1 4.2%
Combination	11 45.8%
Fistzpatrick Skin Type (participants) [Number]
I	2 8.3%
II	15 62.5%
III	5 20.8%
IV	2 8.3%
V	0 0%
VI	0 0%

Outcome Measures

1. Primary Outcome

Title	Rosacea Score on the Visual Analog Scale
Description	VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
Time Frame	Baseline, Weeks 2, 6, and 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.

Arm/Group Title	Oracea
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea
Measure Participants	22
Baseline	4.50 (1.81)
Week 2	4.52 (1.87)
Week 6	3.77 (1.93)
Week 12	3.06 (2.34)

2. Secondary Outcome

Title	Rosacea-Specific Quality of Life Index
Description	ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)
Time Frame	Baseline, Weeks 2, 6, and 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.

Arm/Group Title	Oracea
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea
Measure Participants	22
Baseline	3.34 (0.55)
Week 2	3.07 (0.56)
Week 6	2.89 (0.81)
Week 12	2.85 (0.86)

3. Secondary Outcome

Title	Patient Global Assessment (PGA) of Rosacea Scores
Description	Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules
Time Frame	Baseline, Weeks 2, 6, and 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0 = Clear	1 = Near Clear	2 = Mild	3 = Moderate	4 = Severe
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
Measure Participants	22	22	22	22	22
Baseline	0 0%	1 NaN	17 NaN	4 NaN	0 NaN
Week 2	0 0%	4 NaN	16 NaN	2 NaN	0 NaN
Week 6	0 0%	10 NaN	11 NaN	1 NaN	0 NaN
Week 12	3 12.5%	14 NaN	4 NaN	1 NaN	0 NaN

4. Secondary Outcome

Title	Patient Satisfaction Question
Description	The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.
Time Frame	Week 2, 6, and 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Very Satisfied	Satisfied	Neither Satisfied Nor Dissatisfied	Dissatisfied	Very Dissatisfied
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
Measure Participants	22	22	22	22	22
Week 2	1 4.2%	11 NaN	8 NaN	2 NaN	0 NaN
Week 6	4 16.7%	7 NaN	8 NaN	2 NaN	1 NaN
Week 12	8 33.3%	6 NaN	5 NaN	2 NaN	1 NaN

Adverse Events

Time Frame	12 Weeks
Arm/Group Title	Oracea
Arm/Group Description	Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks Oracea
All Cause Mortality
	Oracea
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Oracea
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Other (Not Including Serious) Adverse Events
	Oracea
	Affected / at Risk (%)	# Events
Total	7/24 (29.2%)
Gastrointestinal disorders
Diarrhea	2/24 (8.3%)
Vomiting	3/24 (12.5%)
Respiratory, thoracic and mediastinal disorders
Cough	2/24 (8.3%)

Limitations/Caveats

[Not Specified]

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.