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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00416585
Other study ID # src-hmnm-1385
Secondary ID
Status Completed
Phase Phase 1
First received December 27, 2006
Last updated January 22, 2008
Start date October 2005
Est. completion date November 2006

Study information

Verified date January 2008
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
isotretinoin (Roaccutane)


Locations

Country Name City State
Iran, Islamic Republic of Shaheed Beheshti Medical University, Skin research center Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray before the treatment
Secondary serum levels of Ca, P, PTH and vitamin D metabolites and lateral chest x-ray after the treatment
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