Alopecia Areata, Cetirizine, Latanoprost, Microneedling-Assisted Delivery
Conditions
Brief summary
This study planned to measure the effectiveness and safety of microneedling aided administration of cetirizine 1% versus latanoprost 0.01% in alopecia areata.
Detailed description
Alopecia areata (AA) is a chronic inflammatory disease affecting the hair follicles with a possible multifactorial origin, most prominently in genetically predisposed patients. It is a common cause of non scarring hair loss that presents in a patchy, confluent, or diffuse pattern. The onset may be at any age and there is no known race or sex preponderance. The treatment of AA depends on the severity and extent of the disease. Treatment options include topical or intralesional corticosteroids, phototherapy, topical irritants, topical minoxidil, topical tacrolimus, topical vitamin D analogs and platelet rich plasma injection. For resistant cases, psoralen with ultraviolet A light, oral cyclosporine and other immunosuppressants could be beneficial. Microneedling therapy is becoming popular in management of acne scars and also for facial rejuvenations. Recently it has been shown to stimulate hair growth. The proposed mechanism of action is thought to be stimulation of dermal papilla and stem cells and also increasing the blood supply to the hair follicles. Scalp microneedling is a minimally invasive procedure in which various micro-channels are created by short fine needles to help in penetration and absorption of various agents into the skin. So, microneedling is a promising and effective therapy for the treatment of AA
Interventions
Patinets treated with microneedling-aided administration of topical cetirizine 1% solution
DRUGLatanoprost
Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group
DRUGTriamcinolone Acetonide
Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group
PROCEDUREMicroneedling only
Patientstreated with microneedling only as a negative control group
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Newly diagnosed cases of alopecia areata. * Patients of any age. * Both male and female patients. * Recent-onset patchy alopecia areata of ≤6 months' duration. * Presence of no more than two alopecia patches. * Stationary course of the disease. * Willingness to participate in the study. * Provision of written informed consent or parental/guardian consent for minors.
Exclusion criteria
* Extensive alopecia areata, including alopecia totalis or alopecia universalis. * Previous treatment of the alopecia areata lesions. * Active scalp infection. * Presence of associated dermatological, systemic, or autoimmune comorbidities. * Known allergy or hypersensitivity to any of the planned therapeutic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Alopecia Tool Score (SALT Score) | Baseline and 12 weeks | The Severity of Alopecia Tool (SALT) score was used to assess the extent of scalp hair loss. The score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. Changes in SALT score from baseline was compared between the treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global assessment of hair regrowth | Baseline and at the end of the 12-week treatment period | Hair regrowth was evaluated by the investigator using standardized clinical photographs and a global assessment scale. The degree of hair regrowth was graded on a 5-point scale ranging from 0 (no regrowth) to 4 (excellent regrowth, ≥75%), with higher scores indicating greater clinical improvement. Assessments were performed at baseline and at the end of the 12-week treatment period. |
| Adverse events | Throughout the 12-week study period. | Complications, including pain, erythema, edema, pruritus, infection, post-inflammatory hyperpigmentation, allergic reactions, and any other local or systemic adverse events |
Countries
Egypt
Outcome results
None listed