Seborrheic DermatitisNCT01203189
Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
A study testing ketoconazole 2% foam in people with Seborrheic Dermatitis, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- ketoconazole 2% foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis University Department of Dermatology
St Louis, Missouri, 63104
About this study
Official title: Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
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.
Read the 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.
- Conditions
- Seborrheic Dermatitis
- Being tested
- ketoconazole 2% foam, ketoconazole 2% shampoo
- Keywords
- dandruff, flaky scalp
- Medical subject headings
- Dermatitis, Seborrheic, Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoconazole 2% foamDrug
Also called Extina
Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
ketoconazole 2% shampooDrug
Also called Nizoral
Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
| Study group | Role | What they receive |
|---|---|---|
| Shampoo Group | Active comparator | Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. Receives: Drug: ketoconazole 2% shampoo |
| Foam group | Active comparator | Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. Receives: Drug: ketoconazole 2% foam |
| Cross Over Group | Active comparator | apply ketoconazole 2% foam to scalp twice daily for four weeks. 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 using shampoo. Receives: Drug: ketoconazole 2% foam; Drug: ketoconazole 2% shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 8 weeks
Secondary outcomes (2)
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.
Measured: at end of each treatment period (4 weeks and 8 weeks)
Number of Participants Who Are Very Satisfied
Patient satisfaction will be measured using a five point satisfaction scale.
- very dissatisfied
- dissatisfied
- Neutral
- satisfied
- very satisfied.
Measured: data were collected at end of each treatment period (4 weeks and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aibing M. Guo, MD, St. Louis University
- Investigators
- Aibing M Guo, M.D., Principal investigator, St. Louis University DermatologyScott W Fosko, M.D., Study chair, St. Louis University Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203189
- Sponsor's protocol ID
- seb derm 2010
- Status last verified
- Oct 2017
- First submitted
- 14 Sep 2010
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
- ClinicalTrials.gov ID
- NCT01203189
- Acronym / sponsor ID
- seb derm 2010
- Conditions
- Seborrheic Dermatitis
- Keywords
- dandruff, flaky scalp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shampoo Group | Active comparator | Drug: ketoconazole 2% shampooSubjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. |
| Foam group | Active comparator | Drug: ketoconazole 2% foamSubjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. |
| Cross Over Group | Active comparator | Drug: ketoconazole 2% foam, Drug: ketoconazole 2% shampooapply ketoconazole 2% foam to scalp twice daily for four weeks. 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 using shampoo. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketoconazole 2% foamAlso: ExtinaSubjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. | Drug | Cross Over Group, Foam group |
| ketoconazole 2% shampooAlso: NizoralSubjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. | Drug | Cross Over Group, Shampoo Group |
Primary outcome
Total Dandruff Severity Score (TDSS)
Time frame: 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
2 secondary outcomes
Number of Participants Who Are Always Compliant.
Time frame: at end of each treatment period (4 weeks and 8 weeks)
Number of Participants Who Are Very Satisfied
Time frame: data were collected at end of each treatment period (4 weeks and 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aibing M Guo, M.D. principal investigator
St. Louis University Dermatology
Scott W Fosko, M.D. study chair
St. Louis University Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketoconazole 2% foam in people with Seborrheic Dermatitis, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Dandruff Severity Score (TDSS) (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.