Trial Outcomes & Findings for Combination Gel and Vascular ND in Mild to Moderate Rosacea (NCT NCT01631656)

Results Overview

Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or "No inflammatory signs of rosacea" to 6 = "Severe inflammatory signs of rosacea."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Azelaic Acid Left Side Plus Laser Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.	Azelaic Acid Right Side Plus Laser Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Gel and Vascular ND in Mild to Moderate Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azelaic Acid Left Side Plus Laser n=5 Participants Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.	Azelaic Acid Right Side Plus Laser n=5 Participants Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.	Total n=10 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
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or "No inflammatory signs of rosacea" to 6 = "Severe inflammatory signs of rosacea."

Outcome measures

Outcome measures
Measure	Azelaic Acid Plus Laser n=10 Participants Azelaic acid 15% twice daily for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser of half the face, once at Week 2.	LASER ONLY n=10 Participants Laser treatment with no azelaic acid on one side of face
IGA of Improvement	3.1 units on a scale Standard Deviation 1.2	3.5 units on a scale Standard Deviation 1.4

Adverse Events

Azelaic Acid Plus Laser

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Laser Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Azelaic Acid Plus Laser n=10 participants at risk Azelaic acid 15% twice daily for 6 weeks on one side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.	Laser Only n=10 participants at risk Laser treatment with no azelaic acid on one side of face
Musculoskeletal and connective tissue disorders herniated disc	10.0% 1/10 • Number of events 1 • 6 weeks	0.00% 0/10 • 6 weeks
Skin and subcutaneous tissue disorders Burning	30.0% 3/10 • Number of events 3 • 6 weeks	0.00% 0/10 • 6 weeks

Additional Information

Dr Amy McMichael

WakeForest University Health Sciences

Phone: 336-716-3775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place