NCT00416585

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
Last Updated

January 23, 2008

Status Verified

January 1, 2008

First QC Date

December 27, 2006

Last Update Submit

January 22, 2008

Conditions

Acne

Keywords

acneisotretinoincalcium. vitamin D

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

isotretinoin (Roaccutane)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • sever acne

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Beheshti Medical University, Skin research center

Tehran, 198994148, Iran

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • parviz toossi, md

    Skin Research Center

    STUDY CHAIR

  • Hamideh Moravvej, md

    Skin Research Center

    PRINCIPAL INVESTIGATOR

  • Nahid Mohtasham, md

    Skin Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

October 1, 2005

Study Completion

November 1, 2006

Last Updated

January 23, 2008

Record last verified: 2008-01

Locations

IR(1)