Dermatitis, AtopicPhase 3NCT01011621
Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis
A Phase 3 study testing 0.5% prednisolone acetate cream and 0.1% betamethasone valerate cream in people with Dermatitis, Atopic and Dermatitis, Contact, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
Trial summary
Topical corticosteroids are largely used in dermatology. The major problem related to their use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and antiproliferative) may lead to adverse events. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Dermatitis, Atopic, Dermatitis, Contact, Dermatitis, Seborrheic
- What is being tested?
- 0.5% prednisolone acetate cream and 0.1% betamethasone valerate cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2012
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects with corticosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis, psoriasis) mild to moderate in intensity;
- Compliance of the subject to the treatment protocol;
- Agreement with the terms o the informed consent by the participants
- Subjects who did not use the following medicines before inclusion: topical corticosteroids or other therapies to dermatitis (30 days); oral corticosteroids (180 days); parenteral corticosteroids (180 days); immunomodulators/immunosuppressor (30 days); any drug under investigation (1 year); any therapy for the studied clinical conditions (180 days); keratolytic agents (30 days); emollient agents (30 days); tazarotene (30 days); vitamin D (topical or oral, 30 days); methotrexate (30 days); acitretin (2 years); UV light (30 days); PUVA therapy (30 days).
Who cannot join
- Pregnancy or risk of pregnancy
- Lactation
- History of allergy of any component of the formulations
- Other conditions considered by the investigator as reasonable for non-eligibility
- HIV positivity
- Drug abuse
- Subjects without previous response to topical corticosteroids
- Subjects with intense sun exposure within 15 days of the screening
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis
Topical corticosteroids are largely used in dermatology. The major problem related to their use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and antiproliferative) may lead to adverse events. Conditions sensitive to corticosteroids require formulations with mild to moderate potency while high-potency corticosteroids era required in less responsive conditions. The aim of the present study is to compare the safety and efficacy of prednisolone acetate 0.5% cream (mild-potency non-fluoridated corticosteroid) versus betamethasone valerate 0.1% cream (high-potency fluoridated corticosteroid) in the treatment of mild to moderate cortisosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis and psoriasis). The study hypothesis is that 0.5% prednisolone cream will be as effective as 0.1% betamethasone cream and will be an alternative option to treat corticosensitive dermatosis in body areas where the use of fluoridated corticosteroids is contraindicated, such as the face.
- Being tested
- 0.5% prednisolone acetate cream, 0.1% betamethasone valerate cream
- Keywords
- Prednisolone acetate, Betamethasone valerate
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Contact, Dermatitis, Seborrheic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% prednisolone acetate creamDrug
Small amount applied over the lesion twice a day for 14 days.
0.1% betamethasone valerate creamDrug
Small amount applied over the lesion twice a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% prednisolone acetate cream | Experimental | Not described Receives: Drug: 0.5% prednisolone acetate cream |
| 0.1% betamethasone valerate cream | Active comparator | Not described Receives: Drug: 0.1% betamethasone valerate cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis.
Measured: 14 days
Secondary outcomes (1)
Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mário C Pires, MD, Principal investigator, Hospital Padre Bento de GuarulhosRoberta F. J. Criado, MD, Principal investigator, Faculdade d Medicina do ABCAdilson Costa, MD, Principal investigator, KOLderma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011621
- Sponsor's protocol ID
- PRE/P/08-1
- Status last verified
- Nov 2009
- First submitted
- 9 Nov 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis
- ClinicalTrials.gov ID
- NCT01011621
- Acronym / sponsor ID
- PRE/P/08-1
- Keywords
- Prednisolone acetate, Betamethasone valerate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (estimated)
- First posted
- 11 Nov 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.
Topical corticosteroids are largely used in dermatology. The major problem related to their use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and antiproliferative) may lead to adverse events. Conditions sensitive to corticosteroids require formulations with mild to moderate potency while high-potency corticosteroids era required in less responsive conditions. The aim of the present study is to compare the safety and efficacy of prednisolone acetate 0.5% cream (mild-potency non-fluoridated corticosteroid) versus betamethasone valerate 0.1% cream (high-potency fluoridated corticosteroid) in the treatment of mild to moderate cortisosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis and psoriasis). The study hypothesis is that 0.5% prednisolone cream will be as effective as 0.1% betamethasone cream and will be an alternative option to treat corticosensitive dermatosis in body areas where the use of fluoridated corticosteroids is contraindicated, such as the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% prednisolone acetate cream | Experimental | Drug: 0.5% prednisolone acetate cream |
| 0.1% betamethasone valerate cream | Active comparator | Drug: 0.1% betamethasone valerate cream |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects with corticosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis, psoriasis) mild to moderate in intensity;
- Compliance of the subject to the treatment protocol;
- Agreement with the terms o the informed consent by the participants
- Subjects who did not use the following medicines before inclusion: topical corticosteroids or other therapies to dermatitis (30 days); oral corticosteroids (180 days); parenteral corticosteroids (180 days); immunomodulators/immunosuppressor (30 days); any drug under investigation (1 year); any therapy for the studied clinical conditions (180 days); keratolytic agents (30 days); emollient agents (30 days); tazarotene (30 days); vitamin D (topical or oral, 30 days); methotrexate (30 days); acitretin (2 years); UV light (30 days); PUVA therapy (30 days).
Key exclusion criteria (8 listed)
- Pregnancy or risk of pregnancy
- Lactation
- History of allergy of any component of the formulations
- Other conditions considered by the investigator as reasonable for non-eligibility
- HIV positivity
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 |
|---|---|---|
| 0.5% prednisolone acetate creamSmall amount applied over the lesion twice a day for 14 days. | Drug | 0.5% prednisolone acetate cream |
| 0.1% betamethasone valerate creamSmall amount applied over the lesion twice a day for 14 days. | Drug | 0.1% betamethasone valerate cream |
Primary outcome
Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis.
Time frame: 14 days
1 secondary outcome
Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
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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.
Mário C Pires, MD principal investigator
Hospital Padre Bento de Guarulhos
Roberta F. J. Criado, MD principal investigator
Faculdade d Medicina do ABC
Adilson Costa, MD principal investigator
KOLderma
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.5% prednisolone acetate cream and 0.1% betamethasone valerate cream in people with Dermatitis, Atopic and Dermatitis, Contact, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
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 4 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: status not confirmed, as of the sponsor's last update on 11 Nov 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cláudia Domingues (55115188.5237, cdomingues@mantecorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis. (time frame: 14 days). 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 11 Nov 2009.