Seborrhoeic Eczema of the ScalpPhase 3NCT01137331
K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
A Phase 3 study testing K301 in people with Seborrhoeic Eczema of the Scalp, run by Moberg Pharma AB at 19 sites in Sweden.
Trial summary
Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Seborrhoeic Eczema of the Scalp
- What is being tested?
- K301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 19 sitesSweden
- Study dates
- Feb 2008to Apr 2008
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (including fertile women)
- 18-70 years of age
- Seborrhoeic eczema of the scalp for at least 2 months
- Presenting erythema and desquamation of mild to moderate intensity
- Signed written informed consent
Who cannot join
- Seborrhoeic eczema or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, 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
- Seborrhoeic eczema associated with Parkinson's disease or HIV infection
- Current or any history of ear, nose, and throat carcinoma
- Current or any history of severe concomitant disease according to Investigator's judgement
- Allergy to any of the tested treatment components
- Subject who has been previously enrolled in the phase II study K40-3 investigating Kaprolac® K40
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Sweden19 sites
Läkarhuset Farsta Centrum
Färsta
Hedgrindhälsan AB
Gävle
Centrumläkarna
Gothenburg
Kristinelundskliniken Hudläkarmottagningen
Gothenburg
Me3plus clinical trials
Gothenburg
Fruängens Läkarhus
Hägersten
Hudmottagningen
Helsingborg
Familjehälsan
Hofors
Din doktor i Stockholm AB
Huddinge
Capio Cityklinik
Kristianstad
Limhamns Läkargrupp- Tärnan
Limhamn
Hudläkarna i Linköping
Linköping
Center för Läkemedelsprövningar
Malmö
Hudkliniken UMAS
Malmö
Möllevångens Husläkargrupp
Malmö
Hjortens VC
Trollhättan
VC Silentzvägen Praktikertjänst
Uddevalla
Hälsojouren
Uppsala
Läkarhuset Uppsala
Uppsala
About this study
Official title: A Multicenter, Randomised, Double Blind, Placebo-controlled Study of Efficacy, Safety, and Tolerability of Kaprolac® K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population.
In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE.
The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.
- Conditions
- Seborrhoeic Eczema of the Scalp
- Being tested
- K301, Placebo
- Keywords
- seborrhoeic eczema, scalp, dandruff, K301, K40
- 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.
K301Drug
Also called K40
Liquid- applied once daily prior to bed
PlaceboDrug
Liquid- applied once daily prior to bed
| Study group | Role | What they receive |
|---|---|---|
| K301 | Experimental | K301 applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning. Receives: Drug: K301 |
| Placebo | Placebo comparator | Placebo applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can 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
The sum of erythema and desquamation scores at Week 4
Measured: Week 4
Secondary outcomes (9)
Erythema and desquamation scores
The sum of erythema and desquamation scores at Week 2
Measured: Week 2
Erythema score
Erythema score at Week 2 and 4
Measured: Weeks 2 and 4
Desquamation score
Desquamation score at Week 2 and 4
Measured: Weeks 2 and 4
Investigator's global evaluation
Investigator's global evaluation at Week 4
Measured: Week 4
Patient's global evaluation
Patient's global evaluation at Week 4
Measured: Week 4
Pruritus/burning score
Patient's pruritus/burning score at Week 2 and 4
Measured: Weeks 2 and 4
Dandruff score
Patient's dandruff score at Week 2 and 4
Measured: Weeks 2 and 4
Proportion of responders
Proportion of responders at Week 2 and 4
Measured: Weeks 2 and 4
Adverse events
Adverse events classified by body system and preferred term
Measured: Weeks 2, 4 and 5
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 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrhoeic Eczema 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Åke Svensson, MD, PhD, Principal investigator, Hudkliniken UMAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137331
- Sponsor's protocol ID
- K301-I
- 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 Kaprolac® K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
- ClinicalTrials.gov ID
- NCT01137331
- Acronym / sponsor ID
- K301-I
- Conditions
- Seborrhoeic Eczema of the Scalp
- Keywords
- seborrhoeic eczema, scalp, dandruff, K301, K40
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (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 eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population.
In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE.
The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K301 | Experimental | Drug: K301K301 applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female (including fertile women)
- 18-70 years of age
- Seborrhoeic eczema of the scalp for at least 2 months
- Presenting erythema and desquamation of mild to moderate intensity
- Signed written informed consent
Key exclusion criteria (8 listed)
- Seborrhoeic eczema or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, 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
- Seborrhoeic eczema associated with Parkinson's disease or HIV infection
- Current or any history of ear, nose, and throat carcinoma
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 |
|---|---|---|
| K301Also: K40Liquid- applied once daily prior to bed | Drug | K301 |
| PlaceboLiquid- applied once daily prior to bed | Drug | Placebo |
Primary outcome
Erythema and desquamation scores
Time frame: Week 4
The sum of erythema and desquamation scores at Week 4
9 secondary outcomes
Erythema and desquamation scores
Time frame: Week 2
Erythema score
Time frame: Weeks 2 and 4
Desquamation score
Time frame: Weeks 2 and 4
Investigator's global evaluation
Time frame: Week 4
Patient's global evaluation
Time frame: Week 4
Pruritus/burning score
Time frame: Weeks 2 and 4
Dandruff score
Time frame: Weeks 2 and 4
Proportion of responders
Time frame: Weeks 2 and 4
Adverse events
Time frame: Weeks 2, 4 and 5
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.
Åke Svensson, MD, PhD principal investigator
Hudkliniken UMAS
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing K301 in people with Seborrhoeic Eczema of the Scalp, run by Moberg Pharma AB at 19 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 19 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 phase mean?
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.