Trial · NCT01203189
Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
NCT01203189, Not applicable, Completed, St. Louis University; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo. Trials, record NCT01203189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01203189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
- NCT number
- NCT01203189
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 23 participants, actual
- Lead sponsor
- St. Louis University
- Conditions
- Seborrheic Dermatitis
- Interventions
- ketoconazole 2% foam, ketoconazole 2% shampoo
- First posted
- 2010-09-16
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
- Limitations and caveats
1. Small Sample Size.~2. Unable to control for wash frequency between the two groups, i.e. shampoo group vs foam group.~3. Study group was comprised of patients with moderate seborrheic dermatitis, results may vary in mild or severe cases.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Dandruff Severity Score (TDSS) | up to 8 weeks | The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score. Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome |
| Secondary | Number of Participants Who Are Always Compliant. | at end of each treatment period (4 weeks and 8 weeks) | Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit. a patient is classified as always indicates that they use their medicine as directed on their diary on every visit. |
| Secondary | Number of Participants Who Are Very Satisfied | data were collected at end of each treatment period (4 weeks and 8 weeks) | Patient satisfaction will be measured using a five point satisfaction scale. 1. very dissatisfied 2. dissatisfied 3. Neutral 4. satisfied 5. very satisfied. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Dandruff Severity Score (TDSS) | up to 8 weeks | Data were not collected for the Shampoo only group and Foam Only group at 8 weeks. Only 3 participants completed the 8 weeks of cross over treatment. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Are Always Compliant. | at end of each treatment period (4 weeks and 8 weeks) | Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Are Very Satisfied | data were collected at end of each treatment period (4 weeks and 8 weeks) | Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Dandruff Severity Score (TDSS) | Shampoo Only Group | Baseline TDSS score | 28.6 | Standard Deviation 11.0 | units on a scale |
| Total Dandruff Severity Score (TDSS) | Foam Only Group | Baseline TDSS score | 29.3 | Standard Deviation 13.2 | units on a scale |
| Total Dandruff Severity Score (TDSS) | Cross Over Group | Baseline TDSS score | 26.7 | Standard Deviation 16.2 | units on a scale |
| Total Dandruff Severity Score (TDSS) | Shampoo Only Group | TDSS at 4 weeks | 2.1 | Standard Deviation 3.8 | units on a scale |
| Total Dandruff Severity Score (TDSS) | Foam Only Group | TDSS at 4 weeks | 5.6 | Standard Deviation 7.1 | units on a scale |
| Total Dandruff Severity Score (TDSS) | Cross Over Group | TDSS at 4 weeks | 33.7 | Standard Deviation 19.9 | units on a scale |
| Total Dandruff Severity Score (TDSS) | Cross Over Group | TDSS at 8 weeks | 8.7 | Standard Deviation 0.6 | units on a scale |
| Number of Participants Who Are Always Compliant. | Shampoo Only Group | compliance at week 4 | 7 | Participants | |
| Number of Participants Who Are Always Compliant. | Foam Only Group | compliance at week 4 | 3 | Participants | |
| Number of Participants Who Are Always Compliant. | Cross Over Group | compliance at week 4 | 1 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First 4 Weeks Treatment | STARTED | Shampoo Only Group | 10 | |
| First 4 Weeks Treatment | STARTED | Foam Only Group | 10 | |
| First 4 Weeks Treatment | STARTED | Shampoo First and Then Foam | 3 | |
| First 4 Weeks Treatment | COMPLETED | Shampoo Only Group | 8 | |
| First 4 Weeks Treatment | COMPLETED | Foam Only Group | 8 | |
| First 4 Weeks Treatment | COMPLETED | Shampoo First and Then Foam | 3 | |
| First 4 Weeks Treatment | NOT COMPLETED | Shampoo Only Group | 2 | |
| First 4 Weeks Treatment | NOT COMPLETED | Foam Only Group | 2 | |
| First 4 Weeks Treatment | NOT COMPLETED | Shampoo First and Then Foam | 0 | |
| Cross Over Period 4 Weeks Treatment | STARTED | Shampoo Only Group | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Shampoo Only Group | 0 | 10 |
| Total, all-cause mortality | Foam Only Group | 0 | 10 |
| Total, all-cause mortality | Cross Over Group | 0 | 3 |
| Total, other adverse events | Shampoo Only Group | 0 | 10 |
| Total, other adverse events | Foam Only Group | 0 | 10 |
| Total, other adverse events | Cross Over Group | 0 | 3 |
| Total, serious adverse events | Shampoo Only Group | 0 | 10 |
| Total, serious adverse events | Foam Only Group | 0 | 10 |
| Total, serious adverse events | Cross Over Group | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01203189
GET https://conductscience.org/api/trials/v1/NCT01203189/registered