Alopecia TotalisPhase 4NCT01167946
Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
A Phase 4 study testing methylprednisolone sodium succinate in people with Alopecia Totalis and Alopecia Universalis, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate dosing, inadequate frequency or other factors is a matter of debate. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Alopecia Totalis, Alopecia Universalis, Ophiasic Alopecia
- What is being tested?
- methylprednisolone sodium succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2003to Jul 2010
- Phase
- Phase 4
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Alopecia Universalis
- Alopecia Totalis
- Ophiasic Alopecia
Who cannot join
- diabetes mellitus
- peptic ulcer
- hypertension
- infection
- psychosis
- heart disease
Show all 10Show fewer
- kidney disease
- endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis)
- received systemic or topical treatment within the last 4 weeks before enrollment
- pregnancy
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Khalid University Hospital
Riyadh, Riyadh Region, 11472
About this study
Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate dosing, inadequate frequency or other factors is a matter of debate. The investigators decided to conduct this study using the oral pulse steroid, however with higher doses and more frequent pulses to patients with severe forms of Alopecia areata.
Read the detailed description
This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.
- Conditions
- Alopecia Totalis, Alopecia Universalis, Ophiasic Alopecia
- Being tested
- methylprednisolone sodium succinate
- Keywords
- Alopecia Areata, Alopecia totalis, Alopecia Universalis, Ophiasic alopecia, Oral Pulse steroid, Methylprednisolone
- Medical subject headings
- Alopecia universalis, Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone sodium succinateDrug
Group A will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.
methylprednisolone sodium succinateDrug
Group B will receive 2 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.
methylprednisolone sodium succinateDrug
Group C will receive 3 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks Receives: Drug: methylprednisolone sodium succinate |
| Group B | Active comparator | will receive 2 consecutive daily pulses every 3 weeks for 24 weeks Receives: Drug: methylprednisolone sodium succinate |
| Group C | Active comparator | will receive 3 consecutive daily pulses every 3 weeks for 24 weeks. Receives: Drug: methylprednisolone sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
hair regrowth
Photographs of scalp will be taken before treatment and every 2 visits. Analysis of the photographs will be conducted by two independent dermatologists. Primary efficacy measure will be the proportion of responders at 36 weeks.
Measured: at 36 weeks of treatment
Secondary outcomes (2)
Safety of the protocol
Patients will be monitored for signs and symptoms of adverse events throughout study. Weight, temperature and blood pressure,Electrocardiography and serum electrolytes will be assessed at each visit. The followings will be also performed at specified time frame: complete blood count, blood biochemistry, electrocardiography, Chest x-ray, sinuses x-ray, Short synactin test, Bone mineral density and ophthalmologic examination.
Measured: from the first visit till one year after discontinuation of treatment
Factors affect the response to treatment
Responses will be analyzed in relation to clinical findings and presence of subclinical hypothyroidism, thyroid auto antibodies, antinuclear antibodies, ferritin level, IgE level and the presence and degree of dermal fibrosis, inflammation and epidermal follicular plugging
Measured: at 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJan 2003
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia TotalisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Saudi Society of Dermatology and Dermatologic surgery
- Investigators
- Ghada A Binsaif, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167946
- Sponsor's protocol ID
- 03-451
- Status last verified
- Jan 2003
- First submitted
- 21 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
- ClinicalTrials.gov ID
- NCT01167946
- Acronym / sponsor ID
- 03-451
- Conditions
- Alopecia Totalis, Alopecia Universalis, Ophiasic Alopecia
- Keywords
- Alopecia Areata, Alopecia totalis, Alopecia Universalis, Ophiasic alopecia, Oral Pulse steroid, Methylprednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Saudi Society of Dermatology and Dermatologic surgery
- Study start
- Jan 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Jul 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.
Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate dosing, inadequate frequency or other factors is a matter of debate. The investigators decided to conduct this study using the oral pulse steroid, however with higher doses and more frequent pulses to patients with severe forms of Alopecia areata.
Detailed description
This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: methylprednisolone sodium succinatewill receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks |
| Group B | Active comparator | Drug: methylprednisolone sodium succinatewill receive 2 consecutive daily pulses every 3 weeks for 24 weeks |
| Group C | Active comparator | Drug: methylprednisolone sodium succinatewill receive 3 consecutive daily pulses every 3 weeks for 24 weeks. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Alopecia Universalis
- Alopecia Totalis
- Ophiasic Alopecia
Key exclusion criteria (10 listed)
- diabetes mellitus
- peptic ulcer
- hypertension
- infection
- psychosis
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 |
|---|---|---|
| methylprednisolone sodium succinateGroup A will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice. | Drug | Group A |
| methylprednisolone sodium succinateGroup B will receive 2 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice. | Drug | Group B |
| methylprednisolone sodium succinateGroup C will receive 3 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice. | Drug | Group C |
Primary outcome
hair regrowth
Time frame: at 36 weeks of treatment
Photographs of scalp will be taken before treatment and every 2 visits. Analysis of the photographs will be conducted by two independent dermatologists. Primary efficacy measure will be the proportion of responders at 36 weeks.
2 secondary outcomes
Safety of the protocol
Time frame: from the first visit till one year after discontinuation of treatment
Factors affect the response to treatment
Time frame: at 36 weeks
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 22 Jul 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.
Ghada A Binsaif, MD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylprednisolone sodium succinate in people with Alopecia Totalis and Alopecia Universalis, run by King Saud University at 1 site in Saudi Arabia.
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 3 inclusion and 10 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 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
hair regrowth (time frame: at 36 weeks of treatment). 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 22 Jul 2010.