Trial Outcomes & Findings for Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo (NCT NCT01203189)
NCT ID: NCT01203189
Last Updated: 2017-11-06
Results Overview
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
COMPLETED
NA
23 participants
up to 8 weeks
2017-11-06
Participant Flow
Participant milestones
| Measure |
Shampoo Only Group
Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
|
Foam Only Group
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
Shampoo First and Then Foam
subjects used shampoo for 4 weeks, but did not reach 60% improvement on TDSS score were given foam treatment for 4 weeks
|
|---|---|---|---|
|
First 4 Weeks Treatment
STARTED
|
10
|
10
|
3
|
|
First 4 Weeks Treatment
COMPLETED
|
8
|
8
|
3
|
|
First 4 Weeks Treatment
NOT COMPLETED
|
2
|
2
|
0
|
|
Cross Over Period 4 Weeks Treatment
STARTED
|
0
|
0
|
3
|
|
Cross Over Period 4 Weeks Treatment
COMPLETED
|
0
|
0
|
3
|
|
Cross Over Period 4 Weeks Treatment
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Baseline characteristics by cohort
| Measure |
Shampoo Group
n=10 Participants
Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
|
Foam Group
n=10 Participants
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
Cross Over Group
n=3 Participants
Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
3 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: 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.
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
Outcome measures
| Measure |
Shampoo Only Group
n=8 Participants
Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
|
Foam Only Group
n=8 Participants
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
Cross Over Group
n=3 Participants
Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
|---|---|---|---|
|
Total Dandruff Severity Score (TDSS)
Baseline TDSS score
|
28.6 units on a scale
Standard Deviation 11.0
|
29.3 units on a scale
Standard Deviation 13.2
|
26.7 units on a scale
Standard Deviation 16.2
|
|
Total Dandruff Severity Score (TDSS)
TDSS at 4 weeks
|
2.1 units on a scale
Standard Deviation 3.8
|
5.6 units on a scale
Standard Deviation 7.1
|
33.7 units on a scale
Standard Deviation 19.9
|
|
Total Dandruff Severity Score (TDSS)
TDSS at 8 weeks
|
—
|
—
|
8.7 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: at end of each treatment period (4 weeks and 8 weeks)Population: 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.
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.
Outcome measures
| Measure |
Shampoo Only Group
n=8 Participants
Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
|
Foam Only Group
n=8 Participants
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
Cross Over Group
n=3 Participants
Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
|---|---|---|---|
|
Number of Participants Who Are Always Compliant.
compliance at week 4
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Are Always Compliant.
compliance at week 8
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: data were collected at end of each treatment period (4 weeks and 8 weeks)Population: 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.
Patient satisfaction will be measured using a five point satisfaction scale. 1. very dissatisfied 2. dissatisfied 3. Neutral 4. satisfied 5. very satisfied.
Outcome measures
| Measure |
Shampoo Only Group
n=8 Participants
Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
ketoconazole 2% shampoo: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
|
Foam Only Group
n=8 Participants
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
Cross Over Group
n=3 Participants
Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.
ketoconazole 2% foam: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
|
|---|---|---|---|
|
Number of Participants Who Are Very Satisfied
Very Satisfied at 4 weeks
|
5 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Who Are Very Satisfied
Very Satisfied at 8 weeks
|
—
|
—
|
0 Participants
|
Adverse Events
Shampoo Only Group
Foam Only Group
Cross Over Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aibing Mary Guo, M.D., Assistant Professor
Saint Louis Univ Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place