Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:38 PM
Study NCT ID:
NCT07459933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Methotrexate vs Minoxidil for Localized Alopecia Areata
Sponsor:
Jinnah Postgraduate Medical Centre
Organization:
Study Overview
Official Title:
Comparative Study Between Topical Methotrexate 1% Gel and Minoxidil 5% Spray in the Treatment of Localized Alopecia Areata: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTX-MNX-AA
Brief Summary:
Alopecia areata is an autoimmune disorder characterized by well-defined, non-scarring patches of hair loss on the scalp and other hair-bearing areas. Although several treatment options are available, there is no universally accepted standard therapy, and treatment responses vary widely among patients.
Minoxidil is commonly used for hair regrowth due to its ability to stimulate hair follicles and prolong the anagen phase of the hair cycle. Methotrexate, an immunosuppressive agent traditionally used in inflammatory and autoimmune diseases, has also been explored as a potential treatment for alopecia areata because of its ability to suppress immune-mediated follicular damage.
This randomized controlled trial aims to compare the efficacy and safety of topical methotrexate 1% gel versus minoxidil 5% spray in patients with localized alopecia areata. Eligible participants will be randomly assigned to receive either topical methotrexate gel or minoxidil spray and will be followed for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score. The findings of this study may help identify an effective therapeutic option for patients with localized alopecia areata and contribute to improving clinical management strategies for this condition.
Minoxidil is commonly used for hair regrowth due to its ability to stimulate hair follicles and prolong the anagen phase of the hair cycle. Methotrexate, an immunosuppressive agent traditionally used in inflammatory and autoimmune diseases, has also been explored as a potential treatment for alopecia areata because of its ability to suppress immune-mediated follicular damage.
This randomized controlled trial aims to compare the efficacy and safety of topical methotrexate 1% gel versus minoxidil 5% spray in patients with localized alopecia areata. Eligible participants will be randomly assigned to receive either topical methotrexate gel or minoxidil spray and will be followed for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score. The findings of this study may help identify an effective therapeutic option for patients with localized alopecia areata and contribute to improving clinical management strategies for this condition.
Detailed Description:
Alopecia areata (AA) is a chronic autoimmune disorder characterized by patchy, non-scarring hair loss resulting from immune-mediated damage to hair follicles. The disease affects approximately 2% of the general population during their lifetime and can have significant psychosocial and cosmetic implications for affected individuals. Despite its relatively high prevalence, management of alopecia areata remains challenging due to variable treatment responses and the absence of a universally accepted therapeutic protocol.
Topical minoxidil is widely used in clinical practice for various types of hair loss, including alopecia areata. It promotes hair regrowth by increasing follicular blood flow, prolonging the anagen phase of the hair cycle, and stimulating hair follicle activity. Several studies have demonstrated improvement in hair density and reduction in SALT scores with the use of topical minoxidil.
Methotrexate, a folic acid antagonist with immunosuppressive and anti-inflammatory properties, has traditionally been used for the treatment of autoimmune and inflammatory conditions such as psoriasis and rheumatoid arthritis. Its immunomodulatory effects have also been explored in alopecia areata, where it may reduce the autoimmune response directed against hair follicles. Recent studies have suggested that topical methotrexate formulations may provide clinical benefit with fewer systemic adverse effects compared to oral therapy.
Given the differing mechanisms of action of these two agents-minoxidil acting primarily through follicular stimulation and methotrexate acting through immune modulation-direct comparison of their therapeutic efficacy may provide valuable insights into optimal management strategies for localized alopecia areata.
This randomized controlled trial will be conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible participants aged 18-50 years with localized alopecia areata involving less than 25% of the scalp will be enrolled. Participants will be randomly assigned to receive either topical methotrexate 1% gel or minoxidil 5% spray applied twice daily for a period of 24 weeks.
The primary outcome measure will be improvement in hair regrowth assessed by change in Severity of Alopecia Tool (SALT) score from baseline to week 24. Secondary outcomes will include categorization of treatment response (no change, mild improvement, moderate improvement, significant improvement, or complete regrowth) and assessment of treatment safety through monitoring of adverse events such as local irritation, contact dermatitis, folliculitis, or systemic symptoms.
The results of this study are expected to provide evidence regarding the comparative effectiveness and safety of topical methotrexate and minoxidil in the treatment of localized alopecia areata. This may help guide clinicians in selecting appropriate therapeutic strategies and contribute to improving outcomes for patients affected by this autoimmune hair loss disorder.
Topical minoxidil is widely used in clinical practice for various types of hair loss, including alopecia areata. It promotes hair regrowth by increasing follicular blood flow, prolonging the anagen phase of the hair cycle, and stimulating hair follicle activity. Several studies have demonstrated improvement in hair density and reduction in SALT scores with the use of topical minoxidil.
Methotrexate, a folic acid antagonist with immunosuppressive and anti-inflammatory properties, has traditionally been used for the treatment of autoimmune and inflammatory conditions such as psoriasis and rheumatoid arthritis. Its immunomodulatory effects have also been explored in alopecia areata, where it may reduce the autoimmune response directed against hair follicles. Recent studies have suggested that topical methotrexate formulations may provide clinical benefit with fewer systemic adverse effects compared to oral therapy.
Given the differing mechanisms of action of these two agents-minoxidil acting primarily through follicular stimulation and methotrexate acting through immune modulation-direct comparison of their therapeutic efficacy may provide valuable insights into optimal management strategies for localized alopecia areata.
This randomized controlled trial will be conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible participants aged 18-50 years with localized alopecia areata involving less than 25% of the scalp will be enrolled. Participants will be randomly assigned to receive either topical methotrexate 1% gel or minoxidil 5% spray applied twice daily for a period of 24 weeks.
The primary outcome measure will be improvement in hair regrowth assessed by change in Severity of Alopecia Tool (SALT) score from baseline to week 24. Secondary outcomes will include categorization of treatment response (no change, mild improvement, moderate improvement, significant improvement, or complete regrowth) and assessment of treatment safety through monitoring of adverse events such as local irritation, contact dermatitis, folliculitis, or systemic symptoms.
The results of this study are expected to provide evidence regarding the comparative effectiveness and safety of topical methotrexate and minoxidil in the treatment of localized alopecia areata. This may help guide clinicians in selecting appropriate therapeutic strategies and contribute to improving outcomes for patients affected by this autoimmune hair loss disorder.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: