Study comparing topical Methotrexatel with topical steroids in alopecia areata
- 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
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 88
- 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.
- 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, IndiaDr Amrit MalikPrincipal investigator9811122900amrit.malik259@gmail.com