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NCT00416585 Clinical Trial

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

Acne Clinical Trial

Official title:
Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment

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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