Page last updated: 2024-10-23

azelaic acid and Chronic Illness

azelaic acid has been researched along with Chronic Illness in 3 studies

nonanedioic acid : An alpha,omega-dicarboxylic acid that is heptane substituted at positions 1 and 7 by carboxy groups.

Research Excerpts

Excerpt	Relevance	Reference
"Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation."	6.80	A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. ( Draelos, ZD; Elewski, BE; Harper, JC; Nkulikiyinka, R; Sand, M; Shakery, K; Staedtler, G, 2015)
"Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation."	2.80	A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. ( Draelos, ZD; Elewski, BE; Harper, JC; Nkulikiyinka, R; Sand, M; Shakery, K; Staedtler, G, 2015)
"Because rosacea is a chronic condition, pharmacologic maintenance therapy is necessary to maintain remission."	2.43	Present and future rosacea therapy. ( Wolf, JE, 2005)

Research

Studies (3)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	2 (66.67)	29.6817
2010's	1 (33.33)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Draelos, ZD	1
Elewski, BE	1
Harper, JC	1
Sand, M	1
Staedtler, G	1
Nkulikiyinka, R	1
Shakery, K	1
Wolf, JE	1
Maher, HK	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea[NCT01555463]			Phase 3	961 participants (Actual)	Interventional	2012-09-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment

"The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

Intervention	Scores on a scale (Median)
Azelaic Acid Foam, 15% (BAY39-6251)	0
Vehicle Foam	0

Change From Baseline in Index Value at End of Treatment

"The EuroQol Group Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

Intervention	Scores on a scale (Median)
Azelaic Acid Foam, 15% (BAY39-6251)	0.000
Vehicle Foam	0.000

Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score

"The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant's quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are never (score=1), rarely (score=2), sometimes (score=3), often (score=4), or all the time (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

Intervention	Scores on a scale (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)	-6.8
Vehicle Foam	-6.4

Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)

The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

Intervention	Inflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)	-13.2
Vehicle Foam	-10.3

Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)

The mean (standard deviation) lesion count at the end of treatment is provided. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

Intervention	Inflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)	8.5
Vehicle Foam	10.8

Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)

The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

Intervention	Percent change of inflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)	-61.6
Vehicle Foam	-50.8

Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)

Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)	66.3
Vehicle Foam	54.4

Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)	32.1
Vehicle Foam	23.4

Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)

Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
	Improved	No change	Worse
Azelaic Acid Foam, 15% (BAY39-6251)	61.5	36.9	1.7
Vehicle Foam	51.3	46.2	2.5

Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)

Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
	Improved	No change	Worse
Azelaic Acid Foam, 15% (BAY39-6251)	27.3	65.8	6.8
Vehicle Foam	22.6	69.7	7.7

Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score

"The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant's skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: very much (question 7: yes) (score=3), a lot (score=2), a little (score=1), or not at all/not relevant (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment - baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

Intervention	Participants (Number)
	Score change <=-5	Score change >-5
Azelaic Acid Foam, 15% (BAY39-6251)	107	328
Vehicle Foam	82	349

Participants' Global Assessment of Tolerability at End of Treatment

At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

Intervention	Participants (Number)
	Excellent	Good	Acceptable despite minor irritation	Less acceptable due to continuous irritation	Not acceptable	No opinion
Azelaic Acid Foam, 15% (BAY39-6251)	167	128	112	15	6	7
Vehicle Foam	165	173	49	27	7	11

Participants' Global Assessment of Treatment Response at End of Treatment

At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

Intervention	Participants (Number)
	Excellent improvement	Good improvement	Fair improvement	No improvement	Worse
Azelaic Acid Foam, 15% (BAY39-6251)	75	174	121	57	8
Vehicle Foam	42	151	128	84	27

Participants' Opinion on Cosmetic Acceptability at End of Treatment

At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

Intervention	Participants (Number)
	Very good	Good	Satisfactory	Poor	No opinion
Azelaic Acid Foam, 15% (BAY39-6251)	176	112	95	36	16
Vehicle Foam	124	142	99	46	21

Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment

At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

Intervention	Participants (Number)
	Very good	Good	Satisfactory	Poor	No opinion
Azelaic Acid Foam, 15% (BAY39-6251)	186	143	67	14	25
Vehicle Foam	155	151	75	27	24

Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)

The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
	Clear or almost clear	Mild	Moderate	Severe
Azelaic Acid Foam, 15% (BAY39-6251)	9.3	51.8	34.2	4.8
Vehicle Foam	8.4	41.8	43.1	6.7

Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)

Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
	Normal skin color	Barely visible skin-lightening	Mild skin lightening	Moderate skin lightening	Severe skin lightening
Azelaic Acid Foam, 15% (BAY39-6251)	80.1	8.7	8.3	2.7	0.2
Vehicle Foam	78.7	10.5	7.7	3.1	0

Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)

The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

Intervention	Percentage of participants (Number)
	Clear	Minimal	Mild	Moderate	Severe
Azelaic Acid Foam, 15% (BAY39-6251)	4.6	27.5	34.2	30.2	3.5
Vehicle Foam	4.4	19.0	31.0	38.7	6.9

Reviews

1 review available for azelaic acid and Chronic Illness

Article	Year
Present and future rosacea therapy. Cutis, 2005, Volume: 75, Issue:3 Suppl Topics: Anti-Infective Agents; Biomedical Research; Chronic Disease; Dermatologic Agents; Dicarboxylic Acids	2005

Trials

1 trial available for azelaic acid and Chronic Illness

Article	Year
A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis, 2015, Volume: 96, Issue:1 Topics: Administration, Cutaneous; Adult; Aged; Chronic Disease; Dermatologic Agents; Dicarboxylic Acids; Do	2015

Other Studies

1 other study available for azelaic acid and Chronic Illness

Article	Year
Rosacea. AAOHN journal : official journal of the American Association of Occupational Health Nurses, 2007, Volume: 55, Issue:12 Topics: Anti-Bacterial Agents; Chronic Disease; Dermatologic Agents; Dicarboxylic Acids; Humans; Risk Factor	2007