Seborrheic Dermatitis13244/2009NCT01024374
Evaluation of the Effectiveness of a Product Containing Topical Hydrocortisone in the Treatment of Seborrheic Dermatitis of the Face
An observational study of Seborrheic Dermatitis, run by Allergisa Pesquisa Dermato-Cosmetica LTDA.
Trial summary
Clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of seborrheic dermatitis on the face. Will be held clinical and perceived efficacy assessment and instrumental measurements. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Dermatitis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to not given
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects with seborrheic dermatitis on both sides of the face, both sexes, aged 18 to 60 years, skin types I through IV.
Who may be able to join
- Healthy subjects
- Subjects with seborrheic dermatitis on both sides of the face
- both sexes
- aged 18 to 60 years
- skin types I through IV.
Who cannot join
- pregnancy / lactation
- skin condition in the area of application of the product
- diabetes
- immune insufficiency
- subjects that are using systemic corticoids
- subjects that are using immunosuppressors
Show all 9Show fewer
- skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis
- history of reaction to the product category
- other diseases or medications that might interfere directly in the study or endanger the health of the subject
About this study
Official title: Avaliação da eficácia de um Produto de Uso tópico Contendo Hidrocortisona no Tratamento de Dermatite seborréica na Face.
Clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of seborrheic dermatitis on the face.
Will be held clinical and perceived efficacy assessment and instrumental measurements. Each product will be applied at half face for 7 consecutive days and all applications will be monitored in the research site. 60 volunteers will be recruited.
Evaluations will be held at the following times: T0 - before the initial application of the product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 - 72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days after initiation of treatment.
- Conditions
- Seborrheic Dermatitis
- Medical subject headings
- Dermatitis, Seborrheic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allergisa Pesquisa Dermato-Cosmetica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024374
- Sponsor's protocol ID
- All-E-M-13244-01/02-10-09
- Acronym
- 13244/2009
- Status last verified
- Dec 2009
- First submitted
- 30 Nov 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação da eficácia de um Produto de Uso tópico Contendo Hidrocortisona no Tratamento de Dermatite seborréica na Face.
- ClinicalTrials.gov ID
- NCT01024374
- Acronym / sponsor ID
- 13244/2009 / All-E-M-13244-01/02-10-09
- Conditions
- Seborrheic Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Allergisa Pesquisa Dermato-Cosmetica LTDAIndustry (pharma, biotech, devices)
- Collaborators
- Galderma R&D
- Study start
- Apr 2010
- First posted
- 2 Dec 2009 (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.
Clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of seborrheic dermatitis on the face.
Will be held clinical and perceived efficacy assessment and instrumental measurements. Each product will be applied at half face for 7 consecutive days and all applications will be monitored in the research site. 60 volunteers will be recruited.
Evaluations will be held at the following times: T0 - before the initial application of the product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 - 72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days after initiation of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects with seborrheic dermatitis on both sides of the face, both sexes, aged 18 to 60 years, skin types I through IV.
Key inclusion criteria (5 listed)
- Healthy subjects
- Subjects with seborrheic dermatitis on both sides of the face
- both sexes
- aged 18 to 60 years
- skin types I through IV.
Key exclusion criteria (9 listed)
- pregnancy / lactation
- skin condition in the area of application of the product
- diabetes
- immune insufficiency
- subjects that are using systemic corticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
Related trials for Seborrheic Dermatitis
Not yet recruiting
TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
Cradle Cap, Seborrheic Dermatitis
Not yet recruitingPhase 3
Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis
Seborrheic Dermatitis
RecruitingEarly Phase 1
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Seborrheic Dermatitis
RecruitingPhase 1
ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
Seborrheic Dermatitis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Seborrheic Dermatitis, run by Allergisa Pesquisa Dermato-Cosmetica LTDA.
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 9 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: status not confirmed, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 2 Dec 2009.