Azelaic Acid (topical)
Treatment for Rosacea
Typical Dosage: Apply twice daily
Effectiveness
75%
Safety Score
85%
Clinical Trials
14
Participants
6K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
85
DangerousModerateSafe
Treatment Details
Dosage Range
Apply twice daily
Time to Effect
4-8 weeks
Treatment Duration
12-16 weeks initial, then as needed or maintenance
Evidence Quality
HIGHNumber Needed to Treat (NNT)
5(Treat 5 patients to see 1 additional successful outcome)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$1,500
Monitoring:$300
Side Effect Mgmt:$100
Total Annual:$1,900
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
EXCELLENTICER
$30,000/QALY
QALYs Gained
0.08
Outcome-Based Costs
Cost per Responder
$2,923
Cost per Remission
$5,428
Comparison vs Topical Metronidazole
Cost Difference
$-100/year
Less expensive
QALY Difference
0.00 QALYs
Same outcomes
Dominance
No dominance
Prescription Access Economics
Annual Societal Loss per Patient
$1,300
Cost of prescription-only barriers (visits, time, admin, price premium)
Physician Visit Cost
$300/year
Time Cost
$120/year
Travel + wait time
Insurance Admin Cost
$80/year
Prior auth, claims
Rx Price
$1,500/year
Potential OTC Price
$500/year
Estimated if OTC available
Risk Assessment
Misuse Risk
LOWMissed Diagnosis Risk
LOWAzelaic Acid (topical) Outcomes
for Rosacea
Efficacy Outcomes
Overall Effectiveness
+75%
Response Rate
+65%
Remission Rate
+35%
Common Side Effects
Burning/stinging/itching
+20%
Erythema
+5%
Dryness
+3%
Sources:
Active Clinical Trials
No active trials currently recruiting for this treatment
No active trials found in ClinicalTrials.gov
Completed Clinical Trials
14 completed trials for Azelaic Acid (topical) in Rosacea
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
NCT03094403COMPLETEDPHASE1
1K participants
INTERVENTIONAL
Started: Jul 1, 2016
A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
NCT02120924COMPLETEDPHASE3
1.01K participants
INTERVENTIONAL
Fremont, United States +29 more
Started: Jul 1, 2013
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
NCT00417937COMPLETEDPHASE4
98 participants
INTERVENTIONAL
Berlin, Germany
Started: Jan 1, 2007
A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea
NCT03193372COMPLETED
2.2K participants
OBSERVATIONAL
Palm Harbor, United States
Started: Jul 20, 2017
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
NCT00617903COMPLETEDPHASE2
83 participants
INTERVENTIONAL
Denver, United States +6 more
Started: Jan 1, 2008
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea
NCT03689010COMPLETEDPHASE1
1.12K participants
INTERVENTIONAL
Charlotte, United States
Started: Dec 12, 2017
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
NCT03287791COMPLETEDPHASE3
924 participants
INTERVENTIONAL
Encino, United States +25 more
Started: Jul 19, 2016
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
NCT01555463COMPLETEDPHASE3
961 participants
INTERVENTIONAL
Birmingham, United States +48 more
Started: Sep 1, 2012
Preferences & Treatment Satisfaction Drivers in Rosacea Patients
NCT02602470COMPLETED
206 participants
OBSERVATIONAL
Boston, United States
Started: Jan 8, 2015
Phase 3 Papulopustular Rosacea Study
NCT01494467COMPLETEDPHASE3
688 participants
INTERVENTIONAL
Birmingham, United States +49 more
Started: Dec 1, 2011
Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
NCT00855595COMPLETEDPHASE4
207 participants
INTERVENTIONAL
Birmingham, United States +16 more
Started: Feb 1, 2009
Phase 3 Papulopustular Rosacea Study
NCT01493687COMPLETEDPHASE3
683 participants
INTERVENTIONAL
Birmingham, United States +49 more
Started: Dec 1, 2011
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
NCT01659853COMPLETEDPHASE3
70 participants
INTERVENTIONAL
Evansville, United States +3 more
Started: Sep 1, 2012
ORCA - Oracea® for Rosacea: A Community-based Assessment
NCT00892281COMPLETEDPHASE4
1.42K participants
INTERVENTIONAL
Lexington, United States
Started: Apr 1, 2009