Hair Fall in Patients on Low Dose Methotrexate

January 13, 2016 updated by: Dr.Sharath Kumar, Columbia Asia

Observational Study of Hair Fall in Rheumatoid Arthritis Patients Treated With Low Dose Methotrexate

Low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side effect profile very different from that seen with high dose methotrexate used in oncology. Hair fall has been found to occur in high dose methotrexate but there is no data regarding the same when methotrexate is used in low dose.Thus this observational case control study is being undertaken to determine whether rheumatoid arthritis patients really need to be concerned about hair fall when on low dose methotrexate.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560055
        • Recruiting
        • Columbia Asia Hospitals
        • Principal Investigator:
          • Sharath Kumar, MBBS,MD,DNB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases will consist of consecutive patients diagnosed with rheumatoid arhtiritis in the rheumatology OPD of Columbia Asia hospitals,Bengaluru who are started on methotrexate.

Control population will consist of healthy volunteers (relatives of patients attending the rheumatology OPD or staff in the hospital)

Description

Inclusion Criteria:

For Cases

  • Subjects should be above 18 years of age.
  • Diagnosed with rheumatoid arthritis and fulfilling the ACR EULAR 2010 criteria.
  • Should be initiated on methotrexate
  • Willing to follow up

For Controls

-Subjects should be above 18 years of age.

Exclusion Criteria:

For Cases

  • Subjects with prior exposure to methotrexate in the last 6 months
  • Subjects suffering from Thyroid (hypothyroidism)
  • Subjects on leflunomide, or having received leflunomide in the last 6 months
  • Subjects currently on cyclophosphamide or having received cyclophosphamide in the last 3 months.
  • Subjects on psychiatric treatment or depression illness.
  • Subjects who have overlap with other rheumatological disorders which can cause hair fall.
  • Subjects in 1-5 months of post-partum or post-natal period.
  • Subjects with female pattern baldness
  • Subjects with androgenetic alopecia
  • Subjects with alopecia aereta
  • Subjects with other scalp conditions which can predispose to hair fall

For Controls

  • Subjects having any family history of alopecia.
  • Subjects suffering from thyroid.
  • Subjects having any history of anemia.
  • Subjects under 1-5 months of post-partum or post-natal period.
  • Subjects on medications which can cause hair fall.
  • Subjects on methotrexate for other reasons.
  • Subjects with female pattern baldness
  • Subjects with androgenetic alopecia
  • Subjects with alopecia aereta
  • Subjects with other scalp conditions which can predispose to hair fall

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy Controls
Healthy subject who accompanying patients to rheumatology OPD or healthy subjects who are staff at Columbia Asia Hospital,Bangalore.
Cases (patients on methotrexate)
Subjects attending the rheumatology OPD of Columbia Asia hospitals bengaluru, who are diagnosed as having Rheumatoid arthritis and fulfill the ACR/ EULAR 2010 classification criteria for rheumatoid arthritis and are started on low dose methotrexate will included as cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in number of hair strands obtained by the hair pull test at the baseline and at 3 weeks among RA patients on methotrexate in comparison to the mean change in the same number among controls.
Time Frame: 3 weeks
Mean change in number of hair strands obtained by the hair pull test at the start of the trial and at 3 weeks among rheumatoid arthritis patients on methotrexate in comparison to the mean change in the same number among health controls
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in number of hair strands obtained by the hair pull test at baseline and at 2 months among RA patients on methotrexate in comparison with mean change in the same number among controls.
Time Frame: 2 months
2 months
Mean change in number of hair strands obtained by the hair pull test at the start of the trial and at 3 months among RA patients on methotrexate in comparison to the mean change in the same number among control.
Time Frame: 3 Months
3 Months
Mean difference in number of subjects having an abnormal hair pull test (defined as > 5 hairs) at baseline and at 3 weeks in patients with RA on methotrexate and compare the same with the mean difference.
Time Frame: 3 weeks
3 weeks
Mean difference in number of subjects having an abnormal hair pull test at baseline and at 2 months in patients with RA patients on methotrexate and compare the same with the mean difference.
Time Frame: 2 months
2 months
Mean difference in number of subjects having an abnormal hair pull test at baseline and at 3 months in patients with RA patients on methotrexate and compare the same with the mean difference.
Time Frame: 3 months
3 months
Difference in number of subjects having an anagen hair among the the hair obtained by hair pull test (normal = 0) at 3 weeks between RA patients on methotrexate and controls.
Time Frame: 3 weeks
3 weeks
Difference in number of subjects having an anagen hair among the hair obtained by hair pull test (normal = 0) at 2 months between RA patients on methotrexate and controls.
Time Frame: 2 months
2 months
Difference in number of subjects having an anagen hair among the the hair obtained by hair pull test (normal = 0) at 3 months between rheumatoid arthritis patients on methotrexate and healthy controls.
Time Frame: 3 Months
3 Months
Difference in the mean number of hair obtained at the time of inclusion in the study among rheumatoid arthritis patients and health controls
Time Frame: 0 month
0 month
Determine the difference in number of subjects having an abnormal hair pull test at baseline in patients with RA patients on methotrexate and controls.
Time Frame: 0 month
0 month
Determine the difference in number of subjects having an anagen hair among the the hair obtained by hair pull test (normal = 0) at inclusion in the study between RA patients on methotrexate and healthy controls.
Time Frame: 0 month
0 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia Asia

Investigators

  • Principal Investigator: Sharath Kumar, MBBS,MD,DNB, Columbia Asia Hospitals,Bangalore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/2015/RP/18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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