Introduction
Patients and methods
Study design and study participants
Randomization
Measurements
Primary outcomes
Secondary outcomes
Statistical analysis
Results
Patient screening and baseline characteristics
Parameter | Cetirizine + minoxidil group (N = 26) | Placebo + minoxidil group (N = 27) | P-value (< 0.05) | |
---|---|---|---|---|
Age (years) | 38.61 ± 8.74 | 36.74 ± 9.84 | 0.467a | |
Duration of hair loss (years) | 3.19 ± 1.46 | 3.29 ± 1.87 | 0.823a | |
Sinclair grade | 0.219b | |||
II | 9 (34.6%) | 16 (59.3%) | ||
III | 10 (38.5%) | 7 (25.9%) | ||
IV | 7 (26.9%) | 4 (14.8%) | ||
Fertility | 1.00c | |||
Pre-menopause | 23 (88.5%) | 23 (85.2%) | ||
Post-menopause | 3 (11.5%) | 4 (14.8%) | ||
Family history | 18 (69.2%) | 21 (77.8%) | 0.544b | |
Hirsutism | 4 (15.4%) | 4 (14.8%) | 1.00c | |
Menstrual irregularities | 8 (30.8%) | 8 (29.6%) | 1.00b | |
Acne | 4 (15.4%) | 8 (29.6%) | 0.327c | |
Frontal area trichoscopic parameters | ||||
Terminal hair percentage (%) | 64.73 ± 15.63 | 70.11 ± 12.99 | 0.178a | |
Vellus hair percentage (%) | 35.26 ± 15.63 | 29.88 ± 12.99 | 0.178a | |
Terminal hair density/cm2 | 97.62 ± 32.89 | 107.87 ± 28.63 | 0.231a | |
Vellus hair density/cm2 | 52.77 ± 23.91 | 46.92 ± 24.03 | 0.379a | |
Terminal:vellus | 2.84 ± 3.39 | 3.21 ± 2.31 | 0.646 a | |
Average thickness (µm) | 42.29 ± 10.06 | 46.05 ± 8.93 | 0.155a | |
Average number of hairs/follicular unit | 1.49 ± 0.22 | 1.56 ± 0.25 | 0.332a | |
Vertex area trichoscopic parameters | ||||
Terminal hair percentage (%) | 67.90 ± 13.63 | 71.74 ± 15.05 | 0.335a | |
Vellus hair percentage (%) | 32.12 ± 13.60 | 28.25 ± 15.05 | 0.331a | |
Terminal hair density/cm2 | 104.75 ± 36.42 | 113.80 ± 33.07 | 0.348a | |
Vellus hair density/cm2 | 49.22 ± 23.25 | 43.15 ± 27.65 | 0.393a | |
Terminal:vellus | 3.24 ± 3.98 | 4.17 ± 4.69 | 0.439 a | |
Average thickness (µm) | 43.81 ± 9.31 | 47.41 ± 10.32 | 0.188a | |
Average number of hairs/follicular unit | 1.60 ± 0.33 | 1.63 ± 0.29 | 0.742a | |
Patient self-assessment | Mean rank | P-value (< 0.05) | ||
(N = 27) | (N = 30) | |||
Hair growth | 31.44 | 26.80 | 0.269d | |
New hairs | 29.15 | 28.87 | 0.968d | |
Bald areas | 31.06 | 27.15 | 0.262d | |
Hair loss | 29.30 | 28.73 | 0.850d | |
Satisfaction | 29.46 | 28.58 | 0.831d |
Trichoscopic evaluation
Trichoscopic parameter | Cetirizine + minoxidil group (N = 26) Mean ± SD | Placebo + minoxidil group (N = 27) Mean ± SD | |||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | 12 weeks | 24 weeks | P-value (t)* | Baseline | 12 weeks | 24 weeks | P-value (t)* | P-value (t × g)* | |
Terminal hair percentage (%) | 64.73 ± 15.63 | 67.71 ± 14.24 | 66.76 ± 13.44 | 0.355a | 70.11 ± 12.99 | 70.25 ± 11.88 | 70.20 ± 12.05 | 0.998a | 0.665b |
Vellus hair percentage (%) | 35.26 ± 15.63 | 32.28 ± 14.24 | 33.23 ± 13.44 | 0.355a | 29.88 ± 12.99 | 29.74 ± 11.88 | 29.79 ± 12.05 | 0.998a | 0.665b |
Terminal hair density/cm2 | 97.62 ± 32.89 | 120.45 ± 36.73 | 177.43 ± 43.15 | < 0.0005*a | 107.87 ± 28.63 | 133.44 ± 35.73 | 197.36 ± 43.07 | < 0.0005*a | 0.549b |
Vellus hair density/cm2 | 52.77 ± 23.91 | 58.12 ± 28.29 | 90.98 ± 42.77 | < 0.0005*a | 46.92 ± 24.03 | 59.08 ± 35.73 | 85.90 ± 40.86 | < 0.0005*a | 0.724b |
Terminal:vellus | 2.84 ± 3.39 | 3.21 ± 3.46 | 2.99 ± 3.60 | 0.378 a | 3.21 ± 2.31 | 3.02 ± 1.86 | 3.19 ± 2.54 | 0.916 a | 0.601b |
Average thickness(µm) | 42.29 ± 10.06 | 43.91 ± 8.53 | 42.37 ± 7.97 | 0.217a | 46.05 ± 8.93 | 47.17 ± 9.38 | 45.12 ± 9.35 | 0.345a | 0.843b |
Average number of hairs/ follicular unit | 1.49 ± 0.22 | 1.68 ± 0.34 | 1.53 ± 0.21 | 0.007*a | 1.56 ± 0.25 | 1.73 ± 0.34 | 1.60 ± 0.28 | 0.062a | 0.965b |
Trichoscopic parameter | Cetirizine + minoxidil group (N = 26) Mean ± SD | Placebo + minoxidil group (N = 27) Mean ± SD | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 12 weeks | 24 weeks | P-value (t)* | Baseline | 12 weeks | 24 weeks | P-value (t)* | P-value (t × g)* | ||
Terminal hair percentage (%) | 67.90 ± 13.63 | 72.11 ± 12.81 | 70.34 ± 13.96 | 0.193a | 71.74 ± 15.05 | 74.01 ± 13.80 | 72.05 ± 10.99 | 0.567a | 0.728b | |
Vellus hair percentage (%) | 32.12 ± 13.60 | 27.88 ± 12.81 | 29.65 ± 13.96 | 0.188a | 28.25 ± 15.05 | 25.98 ± 13.80 | 27.98 ± 11.04 | 0.562a | 0.718b | |
Terminal hair density/cm2 | 104.75 ± 36.42 | 123.35 ± 32.26 | 197.35 ± 42.88 | < 0.0005*a | 113.80 ± 33.07 | 142.17 ± 43.15 | 198.77 ± 42.85 | < 0.0005*a | 0.324b | |
Vellus hair density/cm2 | 49.22 ± 23.25 | 48.56 ± 24.08 | 87.58 ± 47.49 | < 0.0005*a | 43.15 ± 27.65 | 52.54 ± 34.20 | 81.21 ± 43.33 | < 0.0005*a | 0.466b | |
Terminal:vellus | 3.24 ± 3.98 | 5.50 ± 8.13 | 4.14 ± 4.89 | 0.166 a | 4.17 ± 4.69 | 4.05 ± 2.85 | 3.19 ± 1.84 | 0.263 a | 0.174 b | |
Average thickness(µm) | 43.81 ± 9.31 | 47.33 ± 8.15 | 45.65 ± 9.97 | 0.046*a | 47.41 ± 10.32 | 48.66 ± 9.55 | 47.11 ± 8.68 | 0.573a | 0.445b | |
Average number of hairs/follicular unit | 1.60 ± 0.33 | 1.85 ± 0.39 | 1.71 ± 0.22 | 0.008*a | 1.63 ± 0.29 | 1.76 ± 0.29 | 1.77 ± 0.25 | 0.051a | 0.235b |
Patient self-assessment questionnaire
Patients self-assessment parameter | 6 weeks | 12 weeks | ||||||
---|---|---|---|---|---|---|---|---|
Cetirizine + minoxidil group (N = 32) | Placebo + minoxidil group (N = 32) | U- value | P-value* (< 0.05) | Cetirizine + minoxidil group (N = 32) | Placebo + minoxidil group (N = 31) | U- value | P-value* (< 0.05) | |
Mean rank | Mean rank | Mean rank | Mean rank | |||||
Hair growth | 32.61 | 32.9 | 508.5 | 0.958 | 33.77 | 30.18 | 439.5 | 0.419 |
New hairs | 35.28 | 29.72 | 423 | 0.217 | 36.17 | 27.69 | 362.5 | 0.046* |
Bald areas | 29.84 | 35.16 | 427 | 0.229 | 30.09 | 33.97 | 435 | 0.376 |
Hair loss | 33.92 | 31.08 | 466 | 0.540 | 28.72 | 35.39 | 391 | 0.111 |
Satisfaction | 32.16 | 32.84 | 501 | 0.883 | 34.47 | 29.45 | 417 | 0.172 |
Patients self-assessment parameter | 18 weeks | 24 weeks | ||||||
---|---|---|---|---|---|---|---|---|
Cetirizine + minoxidil group (N = 28) | Placebo + minoxidil group (N = 30) | U-value | P-value* (< 0.05) | Cetirizine + minoxidil group (N = 27) | Placebo + minoxidil group (N = 30) | U-value | P-value* (< 0.05) | |
Mean rank | Mean rank | Mean rank | Mean rank | |||||
Hair growth | 31.61 | 27.53 | 361 | 0.365 | 33.81 | 24.67 | 275 | 0.030* |
New hairs | 33.77 | 25.52 | 300.5 | 0.048* | 36.35 | 22.38 | 206.5 | < 0.0005* |
Bald areas | 27.95 | 30.95 | 376.5 | 0.474 | 23.63 | 33.83 | 260 | 0.012* |
Hair loss | 27.09 | 31.75 | 352.5 | 0.230 | 26.06 | 31.65 | 325.5 | 0.082 |
Satisfaction | 31.27 | 27.85 | 370.5 | 0.341 | 33.50 | 24.95 | 283.5 | 0.026* |
Cetirizine + minoxidil group N = 27 | |||||||
---|---|---|---|---|---|---|---|
Patients self-assessment parameter | Baseline | 6 weeks | 12 weeks | 18 weeks | 24 weeks | X2-value | P-value* (< 0.05) |
Mean rank | Mean rank | Mean rank | Mean rank | Mean rank | |||
Hair growth | 1.30 | 2.43 | 3.22 | 3.74 | 4.31 | 81.662 | < 0.0005* |
New hairs | 1.07 | 2.43 | 3.26 | 3.87 | 4.37 | 90.590 | < 0.0005* |
Bald areas | 4.91 | 3.52 | 2.81 | 2.33 | 1.43 | 88.167 | < 0.0005* |
Hair loss | 4.98 | 3.30 | 2.54 | 2.17 | 2.02 | 90.100 | < 0.0005* |
Satisfaction | 1.09 | 2.70 | 3.39 | 3.59 | 4.22 | 86.456 | < 0.0005* |
Placebo + minoxidil group N = 30 | |||||||
---|---|---|---|---|---|---|---|
Hair growth | 1.23 | 2.62 | 3.25 | 3.80 | 4.10 | 89.021 | < 0.0005* |
New hairs | 1.08 | 2.47 | 3.37 | 3.97 | 4.12 | 98.200 | < 0.0005* |
Bald areas | 4.97 | 3.48 | 2.70 | 2.03 | 1.82 | 98.507 | < 0.0005* |
Hair loss | 5.00 | 3.12 | 2.68 | 2.20 | 2.00 | 96.121 | < 0.0005* |
Satisfaction | 1.08 | 2.95 | 3.40 | 3.68 | 3.88 | 88.835 | < 0.0005* |