Scalp Seborrheic DermatitisPhase 3EscapeNCT00862654
Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
A Phase 3 study of Scalp Seborrheic Dermatitis, run by Galderma R&D at 18 sites in 5 countries.
Trial summary
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Seborrheic Dermatitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Mar 2009to Feb 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with moderate to severe scalp Seborrheic Dermatitis
Who cannot join
- Subjects suffering from psoriasis,
- Subjects with a known allergy to one of the components of the test products,
- Female subjects who are pregnant, nursing or planning a pregnancy during the study
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Belgium6 sites
Galderma Investigational Center
Bruges
Galderma Investigational Center
Brussels
Galderma Investigational Center
Geel
Galderma Investigational Center
Ghent
Galderma Investigational Center
Liège
Galderma Investigational Center
Mons
Germany6 sites
Galderma Investigational Center
Berlin
Galderma Investigational Center
Bonn
Galderma Investigational Center
Hamburg
Galderma Investigational Center
Lübeck
Galderma Investigational Center
Mahlow
Galderma Investigational Center
Wuppertal
Mexico4 sites
Galderma Investigational Center
Guadalajara
Galderma Investigational Center
México
Galderma Investigational Center
Naucalpan
Galderma Investigational Center
Zapopan, Jalisco
About this study
Official title: Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.
Read the detailed description
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.
- Conditions
- Scalp Seborrheic Dermatitis
- Being tested
- clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week), clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week), clobetasol propionate shampoo (2/week), ketoconazole shampoo (2/week)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)Drug
Association: clobetasol propionate shampoo \& ketoconazole shampoo
clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)Drug
Association: clobetasol propionate shampoo \& ketoconazole shampoo
clobetasol propionate shampoo (2/week)Drug
Monotherapy with clobetasol propionate shampoo
ketoconazole shampoo (2/week)Drug
Monotherpay ketoconazole shampoo (2/week)
| Study group | Role | What they receive |
|---|---|---|
| C propionate 4/week + Ketoconasole 2/week | Experimental | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) Receives: Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) |
| C propionate 2/week + Ketoconasole 2/week | Experimental | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) Receives: Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) |
| C propionate 2/week | Experimental | Clobetasol propionate shampoo 0.05% (2/week) Receives: Drug: clobetasol propionate shampoo (2/week) |
| Ketoconazole 2/week | Active comparator | Ketoconazole shampoo 2% (2/week) Receives: Drug: ketoconazole shampoo (2/week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Severity Score (TSS): Percent Change From Baseline at Week 4
Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scalp Seborrheic DermatitisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Ortonne, MD, Principal investigator, Nice Hospital (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862654
- Sponsor's protocol ID
- RD.03.SPR.29079
- Acronym
- Escape
- Status last verified
- Aug 2011
- First submitted
- 15 Mar 2009
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0.05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6. doi: 10.1111/j.1365-2133.2011.10269.x.
PubMed 21707573
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT00862654
- Acronym / sponsor ID
- Escape / RD.03.SPR.29079
- Conditions
- Scalp Seborrheic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Posted 12 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.
Detailed description
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C propionate 4/week + Ketoconasole 2/week | Experimental | Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) |
| C propionate 2/week + Ketoconasole 2/week | Experimental | Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) |
| C propionate 2/week | Experimental | Drug: clobetasol propionate shampoo (2/week)Clobetasol propionate shampoo 0.05% (2/week) |
| Ketoconazole 2/week | Active comparator | Drug: ketoconazole shampoo (2/week)Ketoconazole shampoo 2% (2/week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with moderate to severe scalp Seborrheic Dermatitis
Key exclusion criteria (3 listed)
- Subjects suffering from psoriasis,
- Subjects with a known allergy to one of the components of the test products,
- Female subjects who are pregnant, nursing or planning a pregnancy during the study
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 |
|---|---|---|
| clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)Association: clobetasol propionate shampoo \& ketoconazole shampoo | Drug | C propionate 4/week + Ketoconasole 2/week |
| clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)Association: clobetasol propionate shampoo \& ketoconazole shampoo | Drug | C propionate 2/week + Ketoconasole 2/week |
| clobetasol propionate shampoo (2/week)Monotherapy with clobetasol propionate shampoo | Drug | C propionate 2/week |
| ketoconazole shampoo (2/week)Monotherpay ketoconazole shampoo (2/week) | Drug | Ketoconazole 2/week |
Primary outcome
Total Severity Score (TSS): Percent Change From Baseline at Week 4
Time frame: baseline and week 4
Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21707573Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0.05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6. doi: 10.1111/j.1365-2133.2011.10269.x.
- Sponsor general informationLink provided by the sponsor.
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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.
Jean-Paul Ortonne, MD principal investigator
Nice Hospital (France)
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Scalp Seborrheic Dermatitis, run by Galderma R&D at 18 sites in 5 countries.
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 1 inclusion and 3 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium, Germany, Mexico, France, South Korea. 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.
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?
Yes. Results are posted in the registry (first posted 12 Aug 2011). 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 Severity Score (TSS): Percent Change From Baseline at Week 4 (time frame: baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00862654, which also lists 1 linked publication.
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 18 Feb 2021.