Dermatitis, ContactNCT00929981

A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients

An observational study of Dermatitis, Contact, run by Pfizer at 4 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will be a prospective, non-interventional, single arm and open label study, in patients with contact dermatitis requiring systemic steroid therapy with a purpose to obtain the real life effectiveness and tolerability of Medrol in treating contact dermatitis in Indian patients. Read more about this study

Who is it for?: Any age
Conditions the study is for: Dermatitis, Contact
What is being tested?: Tablet Methylprednisolone (4 or 16 mg)
Type of treatment: Pill or oral medicine
How many people: 80 participants
Where: 4 sitesIndia
Study dates: Sep 2009to Sep 2010
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients who have been prescribed oral Medrol Tablets (4 or 16 mg) for treatment of contact dermatitis will be enrolled

Who may be able to join

To be eligible for enrollment in this study, patients must be prescribed oral Medrol tablets (4mg and 16 mg) for contact dermatitis as per the locally approved prescribing information
Medrol tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol tablet will necessarily precede and will be independent of the decision to enroll patient into the study
Only those patients, who are ready to sign an informed consent, will be included in the study
Subject can be contacted through telephone

Who cannot join

Patients who have any other dermatological or systemic condition that may interfere or confound with the study outcome measurements
Patients taking any oral steroid preparation or immunomodulators or have taken any such oral medication during last 15 days before enrollment. NSAIDs (Non Steroidal Anti-Inflammatory Agents) are excluded from the list
Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
Participation in other studies within last 1 month before the current study begins and/or during study participation
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

Trial locations and contacts

4 sites in 1 country.

India4 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 038
Pfizer Investigational Site
Ludhiana, Punjab, 141001
Pfizer Investigational Site
Mumbai, Maharashtra, 400 058
Pfizer Investigational Site
Mumbai, Maharashtra, 421 201

Other trials in India

About this study

Official title: Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects

Conditions: Dermatitis, Contact
Being tested: Tablet Methylprednisolone (4 or 16 mg)
Keywords: Contact Dermatitis, Allergic Dermatitis
Medical subject headings: Dermatitis, Contact, Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tablet Methylprednisolone (4 or 16 mg)Drug
Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information

Study groups in NCT00929981
Study group	Role	What they receive
Oral Methylprednisolone		Not described Receives: Drug: Tablet Methylprednisolone (4 or 16 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
Measured: Second follow-up visit (Day 5-28)

Secondary outcomes (6)

Treatment Status (Success/Failure) of CD at the First Follow-up Visit
The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
Measured: First follow-up visit (between Day 6 to 10 after start of treatment)
Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
Measured: Third follow-up visit (between Day 6 to 10 after EOT)
Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
Measured: Final follow-up visit (between Day 25 to 35 after EOT)
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions.
Measured: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus.
Measured: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred).
Measured: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Sep 2010

First posted30 Jun 2009 (estimated)
Study startSep 2009
Primary completionSep 2010
Study completionSep 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.
Other trials for Dermatitis, ContactStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929981
Sponsor's protocol ID: B0121004
Status last verified: Dec 2018
First submitted: 29 Jun 2009
Last updated: 2 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Glycyrrhetinic Acid and Acute Irritant Dermatitis
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Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
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All Dermatitis, Contact trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects
ClinicalTrials.gov ID: NCT00929981
Acronym / sponsor ID: B0121004
Conditions: Dermatitis, Contact
Keywords: Contact Dermatitis, Allergic Dermatitis
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 30 Jun 2009 (estimated)
Results: Posted 26 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Oral Methylprednisolone	–	Drug: Tablet Methylprednisolone (4 or 16 mg)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who have been prescribed oral Medrol Tablets (4 or 16 mg) for treatment of contact dermatitis will be enrolled

Key inclusion criteria (4 listed)

To be eligible for enrollment in this study, patients must be prescribed oral Medrol tablets (4mg and 16 mg) for contact dermatitis as per the locally approved prescribing information
Medrol tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol tablet will necessarily precede and will be independent of the decision to enroll patient into the study
Only those patients, who are ready to sign an informed consent, will be included in the study
Subject can be contacted through telephone

Key exclusion criteria (5 listed)

Patients who have any other dermatological or systemic condition that may interfere or confound with the study outcome measurements
Patients taking any oral steroid preparation or immunomodulators or have taken any such oral medication during last 15 days before enrollment. NSAIDs (Non Steroidal Anti-Inflammatory Agents) are excluded from the list
Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
Participation in other studies within last 1 month before the current study begins and/or during study participation
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this 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
Tablet Methylprednisolone (4 or 16 mg)Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information	Drug	Oral Methylprednisolone

Primary outcome

Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
Time frame: Second follow-up visit (Day 5-28)
The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.

6 secondary outcomes

Treatment Status (Success/Failure) of CD at the First Follow-up Visit
Time frame: First follow-up visit (between Day 6 to 10 after start of treatment)
Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
Time frame: Third follow-up visit (between Day 6 to 10 after EOT)
Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
Time frame: Final follow-up visit (between Day 25 to 35 after EOT)
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Time frame: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Time frame: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Time frame: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

Results and safety

Results posted to the registry on 26 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medrol	80	80

Primary outcome: Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

Time frame: Second follow-up visit (Day 5-28). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Medrol n = 80
Success	93.8 (86.01 to 97.94)
Failure	6.30 (2.06 to 13.99)

Population analysed: Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medrol	0 of 80 (0%)	1 of 80 (1.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dermatitis, Contact

Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Recruiting
Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series
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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.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dermatitis, Contact, run by Pfizer at 4 sites in India.

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 5 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 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 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?

Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit (time frame: Second follow-up visit (Day 5-28)). 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 NCT00929981.

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 Jan 2019.