Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabol... | NCT00416585

Studies
Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne

NCT00416585

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Jan 23, 2008Estimated

Enrollment

Phase

Phase 1

Conditions

Acne

Interventions

isotretinoin (Roaccutane)

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Dec 27, 2006

First Submission Date that Met QC Criteria

Dec 27, 2006

First Posted Date

Dec 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2008

Last Update Posted Date

Jan 23, 2008Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
isotretinoin (Roaccutane)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray before the treatment

Secondary Outcomes

Measure	Description	Time Frame
serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray after the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sever acne

Exclusion Criteria:

renal disorders
gastrointestinal disorders
skeletal disorders
endocrine disorders
drugs such as glucocorticoids , thiazide diuretics, mineral multivitamins, anti acids, tetracyclines

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
parviz toossi, md	Skin Research Center	Study Chair
Hamideh Moravvej, md	Skin Research Center	Principal Investigator
Nahid Mohtasham, md	Skin Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaheed Beheshti Medical University, Skin research center		Tehran		198994148	Iran

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015474	Isotretinoin

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839

Browse Leaves

Not provided

Browse Branches

Not provided