Hair Fall in Patients on Low Dose Methotrexate

• Conditions: Alopecia; Rheumatoid Arthritis; Methotrexate Adverse Reaction

• Registration Number: NCT02591823
• Lead Sponsor: Columbia Asia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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

Secondary Outcome Measures

Name	Time	Method
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.	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.	3 Months
Determine the difference in number of subjects having an abnormal hair pull test at baseline in patients with RA patients on methotrexate and controls.	0 month
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.	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.	3 weeks
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.	3 months
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.	2 months
Difference in the mean number of hair obtained at the time of inclusion in the study among rheumatoid arthritis patients and health controls	0 month
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.	2 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.	3 weeks
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.	0 month

Trial Locations

Locations (1)

Columbia Asia Hospitals; 🇮🇳 Bangalore, Karnataka, India