Trial · NCT00703846
STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%
NCT00703846, Phase 4, Completed, Stiefel, a GSK Company; results first posted 2012-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%. Trials, record NCT00703846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%
- NCT number
- NCT00703846
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 498 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Dermatitis, Seborrheic
- Interventions
- Ketoconazole
- First posted
- 2008-06-24
- Last updated
- 2017-01-30
- Results first posted
- 2012-02-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Adverse Event (AE) | From baseline through 52 weeks | 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." |
| Secondary | Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. |
| Secondary | Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. |
| Secondary | Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. |
| Secondary | Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. |
| Secondary | Median Number of Flares | From baseline through 52 weeks | 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. |
| Secondary | Median Number of Flare Days | From baseline through 52 weeks | 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. |
| Secondary | Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) | Baseline and Week 52 (or Early Termination) | 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. |
| Secondary | Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) | Baseline and Week 52 (or Early Termination) | 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. |
| Secondary | Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) | Baseline and Week 52 (or Early Termination) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Event (AE) | From baseline through 52 weeks | Safety Analysis Set: all participants who had used the study product at least once | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) | 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. | units on a scale | MEAN |
| SECONDARY | Median Number of Flares | From baseline through 52 weeks | Safety Analysis Set | flares | MEDIAN |
| SECONDARY | Median Number of Flare Days | From baseline through 52 weeks | Safety Analysis Set | flare days | MEDIAN |
| SECONDARY | Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) | Baseline and Week 52 (or Early Termination) | Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) | Baseline and Week 52 (or Early Termination) | Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) | Baseline and Week 52 (or Early Termination) | Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis. | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Event (AE) | Extina (Ketoconazole) 2% | 282 | participants | ||
| Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 4, n=451 | -2 | Standard Deviation 1.02 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 8, n=436 | -2 | Standard Deviation 0.98 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 16, n=405 | -2 | Standard Deviation 0.93 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 26, n=381 | -2 | Standard Deviation 0.91 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 39, n=370 | -2 | Standard Deviation 0.95 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 52 (or Early Termination), n=420 | -2 | Standard Deviation 1.03 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 4, n=451 | -2 | Standard Deviation 1.03 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 8, n=436 | -2 | Standard Deviation 1.00 | units on a scale |
| Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) | Extina (Ketoconazole) 2% | Week 16, n=405 | -2 | Standard Deviation 0.93 | units on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extina (Ketoconazole) 2% | 500 | |
| Overall Study | COMPLETED | Extina (Ketoconazole) 2% | 363 | |
| Overall Study | NOT COMPLETED | Extina (Ketoconazole) 2% | 137 |
Source ClinicalTrials.gov
Adverse events23
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site irritation | General disorders | Extina (Ketoconazole) 2% | 38 | 498 | |
| other | Nasopharyngitis | Infections and infestations | Extina (Ketoconazole) 2% | 41 | 498 | |
| other | Upper respiratory tract infection | Infections and infestations | Extina (Ketoconazole) 2% | 29 | 498 | |
| other | Headache | Nervous system disorders | Extina (Ketoconazole) 2% | 32 | 498 | |
| serious | Coronary artery disease | Cardiac disorders | Extina (Ketoconazole) 2% | 1 | 498 | |
| serious | Intestinal obstruction | Gastrointestinal disorders | Extina (Ketoconazole) 2% | 1 | 498 | |
| serious | Oesophageal rupture | Gastrointestinal disorders | Extina (Ketoconazole) 2% | 1 | 498 | |
| serious | Bile duct stone | Hepatobiliary disorders | Extina (Ketoconazole) 2% | 1 | 498 | |
| serious | Cholecystitis acute | Hepatobiliary disorders | Extina (Ketoconazole) 2% | 1 | 498 | |
| serious | Gastroenteritis | Infections and infestations | Extina (Ketoconazole) 2% | 1 | 498 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Extina (Ketoconazole) 2% | ||
| Total, other adverse events | Extina (Ketoconazole) 2% | 140 | 498 |
| Total, serious adverse events | Extina (Ketoconazole) 2% | 16 | 498 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23377341 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00703846
GET https://conductscience.org/api/trials/v1/NCT00703846/results?page=2