Seborrhoeic Dermatitis of the ScalpPhase 2/3NCT01137630
Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp
A Phase 2/3 study testing K40a and K40b in people with Seborrhoeic Dermatitis of the Scalp, run by Moberg Pharma AB at 11 sites in Sweden.
Trial summary
Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk. The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seborrhoeic Dermatitis of the Scalp
- What is being tested?
- K40a and K40b
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 11 sitesSweden
- Study dates
- Feb 2007to May 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (including fertile women)
- 18-65 years of age
- Seborrhoeic dermatitis of the scalp for at least 2 months
- Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity
- Signed written informed consent
Who cannot join
- Patient on an antifungal, selenium sulphite or corticosteroid therapy within the last 2 weeks prior to start of study treatment
- Any other cutaneous disease of the face requiring a specific topical treatment (corticosteroids, antifungals, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
- Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
- Use of systemic corticosteroids and retinoids during the previous 2 months
- SD associated with Parkinson's disease, human immunodeficiency virus infection
- Current or any history of ear, nose and throat carcinoma,
- Current or any history of severe concomitant disease according to Investigator'sjudgement
- Allergy to any of the tested treatment components
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Sweden11 sites
Dellenkliniken
Delsbo
Läkarhuset Farsta Centrum
Färsta
Stortorgets Hälsocentral
Gävle
Hedesunda Hälsocentral
Hedesunda
Familjehälsan
Hofors
Derbykliniken
Malmö
Möllevångens Läkargrupp,
Malmö
Möllevångens Läkargrupp
Malmö
Österpraktiken
Örebro
Department of Dermatology, Karolinska University Hospital
Stockholm
Hälsojouren
Uppsala
About this study
Official title: A Multicenter, Randomised Double Blind, Placebo Controlled Study of Efficacy, Safety and Tolerability of Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp.
Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk.
The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects.
The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.
- Conditions
- Seborrhoeic Dermatitis of the Scalp
- Being tested
- K40a, K40b, Placebo
- Keywords
- seborrhoeic dermatitis, scalp, K40a, K40b
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K40aDrug
Also called K301a
One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
K40bDrug
One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
PlaceboDrug
One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| K40a | Experimental | K40a is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. Receives: Drug: K40a |
| K40b | Experimental | K40b is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. Receives: Drug: K40b |
| Placebo | Placebo comparator | Placebo is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema and desquamation scores
Sum of erythema and desquamation scores at Week 4
Measured: Week 4
Secondary outcomes (13)
Erythema and desquamation scores
Sum of erythema and desquamation scores at Week 2 and 8
Measured: Weeks 2 and 8
Responder
Responder defined as a patient with complete remission (sum of erythema and desquamation scores=0) or partial remission (sum of scores=1 or 2) at Week 2, 4 and 8
Measured: Weeks 2, 4 and 8
Erythema score
Erythema score at Week 2, 4 and 8
Measured: Weeks 2, 4 and 8
Desquamation score
Desquamation score at Week 2, 4 and 8
Measured: Weeks 2, 4 and 8
Doctor's Global evaluation
Doctor's Global evaluation at Week 4 and 8
Measured: Week 4 and 8
Patient's Global evaluation
Patient's Global evaluation at Week 4 and 8
Measured: Weeks 4 and 8
Pruritus score
Patient's pruritus score at Week 2, 4 and 8
Measured: Weeks 2, 4 and 8
Dandruff score
Patient's dandruff score at Week 2, 4 and 8
Measured: Weeks 2, 4 and 8
Dermatology Life Quality Index
Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
Measured: Week 4 and 8
Ease of application
Cosmetic properties; ease of application at Week 4 and 8
Measured: Weeks 4 and 8
Stickiness
Cosmetic properties; stickiness at Week 4 and 8
Measured: Weeks 4 and 8
Effect on hair quality
Cosmetic properties; effect on hair quality at Week 4 and 8
Measured: Weeks 4 and 8
Adverse events
Adverse Events classified by body system and preferred term
Measured: Weeks 0, 2, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrhoeic Dermatitis of the ScalpStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lennart Emtestam, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137630
- Sponsor's protocol ID
- K40-3
- Status last verified
- Jun 2010
- First submitted
- 3 Jun 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised Double Blind, Placebo Controlled Study of Efficacy, Safety and Tolerability of Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp.
- ClinicalTrials.gov ID
- NCT01137630
- Acronym / sponsor ID
- K40-3
- Conditions
- Seborrhoeic Dermatitis of the Scalp
- Keywords
- seborrhoeic dermatitis, scalp, K40a, K40b
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk.
The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects.
The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| K40a | Experimental | Drug: K40aK40a is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. |
| K40b | Experimental | Drug: K40bK40b is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female (including fertile women)
- 18-65 years of age
- Seborrhoeic dermatitis of the scalp for at least 2 months
- Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity
- Signed written informed consent
Key exclusion criteria (8 listed)
- Patient on an antifungal, selenium sulphite or corticosteroid therapy within the last 2 weeks prior to start of study treatment
- Any other cutaneous disease of the face requiring a specific topical treatment (corticosteroids, antifungals, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
- Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
- Use of systemic corticosteroids and retinoids during the previous 2 months
- SD associated with Parkinson's disease, human immunodeficiency virus infection
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 |
|---|---|---|
| K40aAlso: K301aOne tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. | Drug | K40a |
| K40bOne tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. | Drug | K40b |
| PlaceboOne tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. | Drug | Placebo |
Primary outcome
Erythema and desquamation scores
Time frame: Week 4
Sum of erythema and desquamation scores at Week 4
13 secondary outcomes
Erythema and desquamation scores
Time frame: Weeks 2 and 8
Responder
Time frame: Weeks 2, 4 and 8
Erythema score
Time frame: Weeks 2, 4 and 8
Desquamation score
Time frame: Weeks 2, 4 and 8
Doctor's Global evaluation
Time frame: Week 4 and 8
Patient's Global evaluation
Time frame: Weeks 4 and 8
Pruritus score
Time frame: Weeks 2, 4 and 8
Dandruff score
Time frame: Weeks 2, 4 and 8
Dermatology Life Quality Index
Time frame: Week 4 and 8
Ease of application
Time frame: Weeks 4 and 8
Stickiness
Time frame: Weeks 4 and 8
Effect on hair quality
Time frame: Weeks 4 and 8
Adverse events
Time frame: Weeks 0, 2, 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
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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.
Lennart Emtestam, MD principal investigator
Karolinska University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing K40a and K40b in people with Seborrhoeic Dermatitis of the Scalp, run by Moberg Pharma AB at 11 sites in Sweden.
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 5 inclusion and 8 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 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Erythema and desquamation scores (time frame: Week 4). 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 4 Jun 2010.