AcnePhase 1NCT00416585
Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne
A Phase 1 study testing isotretinoin (Roaccutane) in people with Acne, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- isotretinoin (Roaccutane)
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Oct 2005to Nov 2006
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- sever acne
Who cannot join
- renal disorders
- gastrointestinal disorders
- skeletal disorders
- endocrine disorders
- drugs such as glucocorticoids , thiazide diuretics, mineral multivitamins, anti acids, tetracyclines
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shaheed Beheshti Medical University, Skin research center
Tehran, 198994148
About this study
Official title: Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment
serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne
Read the detailed description
few studies has been done of serum levels Ca, P, PTH and vitamin D metabolites in patients receiving isotretinoin .In this study we measured serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne in 30 patients . the patients had no kown skeletal, endocrine ,renal and gastrointestinal disorders.
- Conditions
- Acne
- Being tested
- isotretinoin (Roaccutane)
- Keywords
- acne, isotretinoin, calcium. vitamin D
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotretinoin (Roaccutane)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray before the treatment
Secondary outcomes (1)
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startOct 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- parviz toossi, md, Study chair, Skin Research CenterHamideh Moravvej, md, Principal investigator, Skin Research CenterNahid Mohtasham, md, Principal investigator, Skin Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416585
- Sponsor's protocol ID
- src-hmnm-1385
- Status last verified
- Jan 2008
- First submitted
- 27 Dec 2006
- Last updated
- 23 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment
- ClinicalTrials.gov ID
- NCT00416585
- Acronym / sponsor ID
- src-hmnm-1385
- Conditions
- Acne
- Keywords
- acne, isotretinoin, calcium. vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Nov 2006
- First posted
- 28 Dec 2006 (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.
serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne
Detailed description
few studies has been done of serum levels Ca, P, PTH and vitamin D metabolites in patients receiving isotretinoin .In this study we measured serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne in 30 patients . the patients had no kown skeletal, endocrine ,renal and gastrointestinal disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- sever acne
Key exclusion criteria (5 listed)
- renal disorders
- gastrointestinal disorders
- skeletal disorders
- endocrine disorders
- drugs such as glucocorticoids , thiazide diuretics, mineral multivitamins, anti acids, tetracyclines
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 |
|---|---|---|
| isotretinoin (Roaccutane) | Drug | – |
Primary outcome
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray before the treatment
1 secondary outcome
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray after the treatment
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 23 Jan 2008.
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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.
parviz toossi, md study chair
Skin Research Center
Hamideh Moravvej, md principal investigator
Skin Research Center
Nahid Mohtasham, md principal investigator
Skin Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing isotretinoin (Roaccutane) in people with Acne, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 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 23 Jan 2008. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray before the 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 23 Jan 2008.