Study comparing topical Methotrexatel with topical steroids in alopecia areata

Not Applicable

Not yet recruiting

• Conditions: Alopecia areata, unspecified,

• Registration Number: CTRI/2023/10/058818
• Lead Sponsor: Amrit Malik

Brief Summary

- This will be a prospective, study conducted at Skin & VD outpatient department, Mahatma Gandhi Medical College & Hospital, Jaipur

- After taking written informed consent, detailed history taking and examination (including general physical examination and cutaneous examination), clinical photograph would be done.

- All patients will be randomized and divided into 2 groups:

- Group A (topical methotrexate 1% gel)

- Group B (topical betamethasone diproprionate 0.05% lotion)

- Group A will receive topical MTX 1% gel twice daily until complete improvement or a maximum period of 12 weeks

- Group B received topical steroid twice daily until complete improvement or a maximum period of 12 weeks

- Follow up of patients will be done at week 3, week 6, week 8 and week 12

- Disease severity will be assessed at baseline and at the end of treatment using standardized scales

- Adverse events and laboratory parameters will be monitored throughout the study

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-16
• Study Start: 2023-10-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Presence of five or fewer patches of alopecia areata, involving less than 40% scalp area 2.
• Stable disease without the appearance of a new patch or increase in the size of the existing patch for at least 15 days.

Exclusion Criteria

• Presence of atypical patterns of alopecia areata eg: ophiasis 2.
• Patients who have received topical or oral treatment for alopecia areata in the past 1 month 3.
• Patients with any other coexisting hair disorder diagnosed based on clinical history and examination (viz., trichotillomania androgenetic alopecia, telogen effluvium) 4.
• Presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy) or methotrexate; 5.
• Pregnant and lactating women 6.
• Unwilling to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare and study the efficacy of topical methotrexate 1% gel & topical betamethasone diproprionate 0.05% lotion in the treatment of alopecia areata	number, size, site and shape of alopecia areata patch compared every 3 weeks at week 0, week 3, week 6, week 12 or until regrowth of short velours hair noticed on dermoscopy

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety & tolerability of topical betamethasone diproprionate 0.05% lotion in the treatment of alopecia areata	Evaluation of adverse effect if present & tolerability noted at week 3, week 6, week 12
To evaluate the safety & tolerability of topical methotrexate 1% gel in the treatment of alopecia areata	Evaluation of adverse effect if present & tolerability noted at week 3, week 6, week 12

Trial Locations

Locations (1)

Mahatma Gandhi Hospital, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Mahatma Gandhi Hospital, Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Amrit Malik

Principal investigator

9811122900

amrit.malik259@gmail.com