Trial Outcomes & Findings for STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2% (NCT NCT00703846)
NCT ID: NCT00703846
Last Updated: 2017-01-30
Results Overview
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events."
COMPLETED
PHASE4
498 participants
From baseline through 52 weeks
2017-01-30
Participant Flow
Participant milestones
| Measure |
Extina (Ketoconazole) 2%
Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening \[BD\]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
363
|
|
Overall Study
NOT COMPLETED
|
137
|
Reasons for withdrawal
| Measure |
Extina (Ketoconazole) 2%
Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening \[BD\]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lost to Follow-up
|
55
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Noncompliance with Study Treatment
|
2
|
|
Overall Study
Withdrawal by Subject
|
40
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
14
|
|
Overall Study
Did Not Receive Study Drug
|
2
|
Baseline Characteristics
STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%
Baseline characteristics by cohort
| Measure |
Extina (Ketoconazole) 2%
n=498 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening \[BD\]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
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|---|---|
|
Age, Continuous
|
47.2 Years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
Gender
Female
|
239 Participants
n=5 Participants
|
|
Gender
Male
|
259 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
108 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
346 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline through 52 weeksPopulation: Safety Analysis Set: all participants who had used the study product at least once
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events."
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=498 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
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|---|---|
|
Number of Participants With Any Adverse Event (AE)
|
282 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)Population: Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.
Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=451 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 4, n=451
|
-2 units on a scale
Standard Deviation 1.02
|
|
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 8, n=436
|
-2 units on a scale
Standard Deviation 0.98
|
|
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 16, n=405
|
-2 units on a scale
Standard Deviation 0.93
|
|
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 26, n=381
|
-2 units on a scale
Standard Deviation 0.91
|
|
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 39, n=370
|
-2 units on a scale
Standard Deviation 0.95
|
|
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 52 (or Early Termination), n=420
|
-2 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)Population: Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.
Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=451 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 4, n=451
|
-2 units on a scale
Standard Deviation 1.03
|
|
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 8, n=436
|
-2 units on a scale
Standard Deviation 1.00
|
|
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 16, n=405
|
-2 units on a scale
Standard Deviation 0.93
|
|
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 26, n=381
|
-2 units on a scale
Standard Deviation 0.98
|
|
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 39, n=370
|
-2 units on a scale
Standard Deviation 1.03
|
|
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 52 (or Early Termination), n=420
|
-2 units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)Population: Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.
Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=451 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 16, n=405
|
-2 units on a scale
Standard Deviation 1.11
|
|
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 4, n=451
|
-2 units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 8, n=436
|
-2 units on a scale
Standard Deviation 1.13
|
|
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 26, n=381
|
-2 units on a scale
Standard Deviation 1.13
|
|
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 39, n=370
|
-2 units on a scale
Standard Deviation 1.07
|
|
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 52 (or Early Termination), n=420
|
-2 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)Population: Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.
This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time ("static"). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=451 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
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|---|---|
|
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 4, n=451
|
-1 units on a scale
Standard Deviation 0.94
|
|
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 8, n=436
|
-2 units on a scale
Standard Deviation 0.91
|
|
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 16, n=405
|
-2 units on a scale
Standard Deviation 0.88
|
|
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 26, n=381
|
-2 units on a scale
Standard Deviation 0.94
|
|
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 39, n=370
|
-2 units on a scale
Standard Deviation 0.98
|
|
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Week 52 (or Early Termination), n=420
|
-2 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: From baseline through 52 weeksPopulation: Safety Analysis Set
The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=498 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
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|---|---|
|
Median Number of Flares
|
7 flares
Interval 1.0 to 68.0
|
SECONDARY outcome
Timeframe: From baseline through 52 weeksPopulation: Safety Analysis Set
The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=498 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Median Number of Flare Days
|
109 flare days
Interval 1.0 to 365.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (or Early Termination)Population: Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=412 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
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|---|---|
|
Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)
|
-11 units on a scale
Standard Deviation 17.90
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (or Early Termination)Population: Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the symptomatic component, participants were asked to answer 7 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of the 7 question scores; total score ranges from 7 to 35.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=412 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)
|
-3 units on a scale
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (or Early Termination)Population: Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the emotional component, participants were asked to answer 10 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of the 10 question scores; total score ranges from 10 to 50.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=412 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)
|
-5 units on a scale
Standard Deviation 7.68
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (or Early Termination)Population: Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the functional component, participants were asked to answer 15 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of the 12 question scores; total score ranges from 15 to 75.
Outcome measures
| Measure |
Extina (Ketoconazole) 2%
n=412 Participants
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)
|
-4 units on a scale
Standard Deviation 8.72
|
Adverse Events
Extina (Ketoconazole) 2%
Serious adverse events
| Measure |
Extina (Ketoconazole) 2%
n=498 participants at risk
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening \[BD\]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.20%
1/498
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/498
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.20%
1/498
|
|
Hepatobiliary disorders
Bile duct stone
|
0.20%
1/498
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
1/498
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/498
|
|
Infections and infestations
Pneumonia
|
0.40%
2/498
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/498
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.20%
1/498
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/498
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastasis
|
0.20%
1/498
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
1/498
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.20%
1/498
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.20%
1/498
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.20%
1/498
|
|
Psychiatric disorders
Psychotic disorder
|
0.20%
1/498
|
|
Psychiatric disorders
Suicide attempt
|
0.20%
1/498
|
|
Renal and urinary disorders
Calculus ureteric
|
0.20%
1/498
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/498
|
Other adverse events
| Measure |
Extina (Ketoconazole) 2%
n=498 participants at risk
Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening \[BD\]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
|
|---|---|
|
General disorders
Application site irritation
|
7.6%
38/498
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
41/498
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
29/498
|
|
Nervous system disorders
Headache
|
6.4%
32/498
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER