Seborrheic Dermatitis
Conditions
Keywords
dandruff, flaky scalp
Brief summary
The aims of this study are to compare the effectiveness of antifungal foam versus antifungal shampoo and determine patient compliance and satisfaction with both vehicles among African American females with dandruff practicing less than once weekly hair washing.
Detailed description
A wide variety of topical vehicles are available for medications that treat scalp disorders. Proper vehicle selection is important when managing scalp conditions, such as seborrheic dermatitis, because the efficacy of these treatments depends largely on compliance and the amount of active ingredient delivered to the scalp. It is therefore important to prescribe vehicles that are easy to apply and cause the least amount of disruption to the patients' pre-existing hair care practices. One of the most common rate limiting hair care practices among different cultures is wash frequency. Literature shows African American women are more likely to wash their hair less than once weekly versus Caucasian women. We hypothesize certain vehicles, such as foam preparations which do not require hair washing, will be more efficacious in African American women with seborrheic dermatitis than shampoo preparations.
Interventions
Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* African American females aged 18 to 89 years * Previous diagnosis of seborrheic dermatitis of the scalp * TDSS between 50 and 200 * Practice less than or equal to once weekly hair washing * Immunocompetent * Willing to not grease or oil scalp
Exclusion criteria
* Age below 18 years or above 89 years * Medical history of psoriasis, diabetes mellitus, immunosuppression, neurologic disorders, and/or chronic disease not stabilized by medication * Patients taking any oral steroids and/or antifungals within 30 days of enrollment * Sensitivity to any formulation components of either ketoconazole foam or shampoo including sulfur * The use of any topical medications including over the counter products indicated for the treatment of seborrheic dermatitis within 14 days of enrollment * Pregnant women, women who plan on becoming pregnant, or breastfeeding women * Current use or history of using any biologic medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shampoo 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. | 10 |
| Foam 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. | 10 |
| Cross Over Group 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. | 3 |
| Total | 23 |
Baseline characteristics
| Characteristic | Shampoo Group | Foam Group | Cross Over Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 3 Participants | 23 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 3 participants | 23 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 3 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 3 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 3 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 3 |
Outcome results
Primary
Total Dandruff Severity Score (TDSS)
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
Time frame: up to 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shampoo Only Group | Total Dandruff Severity Score (TDSS) | TDSS at 4 weeks | 2.1 units on a scale | Standard Deviation 3.8 |
| Shampoo Only Group | Total Dandruff Severity Score (TDSS) | Baseline TDSS score | 28.6 units on a scale | Standard Deviation 11 |
| Foam Only Group | Total Dandruff Severity Score (TDSS) | TDSS at 4 weeks | 5.6 units on a scale | Standard Deviation 7.1 |
| Foam Only Group | Total Dandruff Severity Score (TDSS) | Baseline TDSS score | 29.3 units on a scale | Standard Deviation 13.2 |
| Cross Over Group | Total Dandruff Severity Score (TDSS) | Baseline TDSS score | 26.7 units on a scale | Standard Deviation 16.2 |
| Cross Over Group | Total Dandruff Severity Score (TDSS) | TDSS at 8 weeks | 8.7 units on a scale | Standard Deviation 0.6 |
| Cross Over Group | Total Dandruff Severity Score (TDSS) | TDSS at 4 weeks | 33.7 units on a scale | Standard Deviation 19.9 |
Secondary
Number of Participants Who Are Always Compliant.
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Shampoo Only Group | Number of Participants Who Are Always Compliant. | compliance at week 4 | 7 Participants |
| Foam Only Group | Number of Participants Who Are Always Compliant. | compliance at week 4 | 3 Participants |
| Cross Over Group | Number of Participants Who Are Always Compliant. | compliance at week 4 | 1 Participants |
| Cross Over Group | Number of Participants Who Are Always Compliant. | compliance at week 8 | 0 Participants |
Secondary
Number of Participants Who Are Very Satisfied
Patient satisfaction will be measured using a five point satisfaction scale. 1. very dissatisfied 2. dissatisfied 3. Neutral 4. satisfied 5. very satisfied.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Shampoo Only Group | Number of Participants Who Are Very Satisfied | Very Satisfied at 4 weeks | 5 Participants |
| Foam Only Group | Number of Participants Who Are Very Satisfied | Very Satisfied at 4 weeks | 8 Participants |
| Cross Over Group | Number of Participants Who Are Very Satisfied | Very Satisfied at 4 weeks | 0 Participants |
| Cross Over Group | Number of Participants Who Are Very Satisfied | Very Satisfied at 8 weeks | 0 Participants |