Transdermal Versus Intralesional Betamethasone for Keloids

The version of the Vancouver Scar Scale (VSS) used in this study assesses four scar characteristics: color, thickness, vascularity, and pliability. Color is scored from 0 to 3, thickness from 0 to 4, vascularity from 0 to 3, and pliability from 0 to 5. The total VSS score ranges from 0 to 15. Higher scores indicate greater scar severity and therefore a worse outcome. The primary outcome is the improvement rate in the VSS total score at 24 weeks after the final treatment compared with baseline.

The improvement rate of Vancouver Scar Scale (VSS) scores compared with baseline will be assessed at multiple time points to evaluate treatment efficacy over time.

The Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) consists of six items, each scored from 1 to 10. The total score ranges from 6 to 60. Lower scores indicate scar characteristics more similar to normal skin, whereas higher scores indicate a greater difference from normal skin and therefore a worse outcome.

Patient satisfaction is assessed using a 5-point patient satisfaction rating scale ranging from 0 to 4: 0 = no improvement/poor, 1 = slightly dissatisfied, 2 = neutral, 3 = generally satisfied, and 4 = very satisfied. Higher scores indicate greater patient satisfaction and therefore a better outcome.

Pain intensity is assessed using the Verbal Rating Scale (VRS), with scores ranging from 0 to 4: 0 = no pain, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. Higher scores indicate greater pain intensity and therefore a worse outcome.

The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire assessing the impact of skin disease on health-related quality of life. The total score ranges from 0 to 30. Higher scores indicate greater impairment in quality of life and therefore a worse outcome.

The recurrence rate of keloids will be evaluated within 1 year after treatment based on predefined clinical criteria.

The number and severity of treatment-related adverse events will be recorded throughout the study.

The Observer Scale of the Patient and Observer Scar Assessment Scale (POSAS) consists of five items, each scored from 1 to 10. The total score ranges from 5 to 50. Lower scores indicate scar characteristics more similar to normal skin, whereas higher scores indicate a greater difference from normal skin and therefore a worse outcome.

Pruritus intensity is assessed using the Verbal Rating Scale (VRS), with scores ranging from 0 to 4: 0 = no pruritus, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. Higher scores indicate greater pruritus intensity and therefore a worse outcome.

The Skindex-29 is a dermatology-specific health-related quality-of-life questionnaire. The Symptoms domain score ranges from 0 to 100. Higher scores indicate greater symptom-related impairment in quality of life and therefore a worse outcome.

The Skindex-29 is a dermatology-specific health-related quality-of-life questionnaire. The Emotions domain score ranges from 0 to 100. Higher scores indicate greater emotional impairment related to the skin condition and therefore a worse outcome.

The Skindex-29 is a dermatology-specific health-related quality-of-life questionnaire. The Functioning domain score ranges from 0 to 100. Higher scores indicate greater impairment in daily and social functioning related to the skin condition and therefore a worse outcome.

The Physical Functioning domain of the 36-Item Short Form Health Survey (SF-36) assesses limitations in physical activities due to health. The domain score ranges from 0 to 100. Higher scores indicate better physical functioning and therefore a better outcome.

The Role Limitations Due to Physical Health domain of the 36-Item Short Form Health Survey (SF-36) assesses limitations in work or other daily activities caused by physical health problems. The domain score ranges from 0 to 100. Higher scores indicate fewer role limitations and therefore a better outcome.

The Bodily Pain domain of the 36-Item Short Form Health Survey (SF-36) assesses pain intensity and interference with normal activities. The domain score ranges from 0 to 100. Higher scores indicate less pain and less pain-related interference and therefore a better outcome.

The General Health domain of the 36-Item Short Form Health Survey (SF-36) assesses participants' perceptions of their overall health. The domain score ranges from 0 to 100. Higher scores indicate better perceived general health and therefore a better outcome.

The Vitality domain of the 36-Item Short Form Health Survey (SF-36) assesses energy and fatigue. The domain score ranges from 0 to 100. Higher scores indicate greater vitality and less fatigue and therefore a better outcome.

The Social Functioning domain of the 36-Item Short Form Health Survey (SF-36) assesses the extent to which physical or emotional health interferes with normal social activities. The domain score ranges from 0 to 100. Higher scores indicate better social functioning and therefore a better outcome.

The Role Limitations Due to Emotional Problems domain of the 36-Item Short Form Health Survey (SF-36) assesses limitations in work or other daily activities caused by emotional problems. The domain score ranges from 0 to 100. Higher scores indicate fewer role limitations and therefore a better outcome.

The Mental Health domain of the 36-Item Short Form Health Survey (SF-36) assesses psychological well-being and emotional distress. The domain score ranges from 0 to 100. Higher scores indicate better mental health and therefore a better outcome.

The Symptom Checklist-90 (SCL-90) is a 90-item self-report questionnaire used to assess a broad range of psychological symptoms. Each item is scored from 1 to 5, where higher item scores indicate greater symptom severity. The total score ranges from 90 to 450. Higher total scores indicate greater psychological distress and therefore a worse outcome.

The 9-item version of the Hamilton Depression Rating Scale (HAMD) used in this study assesses depressed mood, feelings of guilt, suicidality, difficulty falling asleep, disturbed sleep, early-morning awakening, work and interests, psychomotor retardation, and agitation. Items are scored on either a 0-to-4 or 0-to-2 scale, yielding a total score ranging from 0 to 28. Higher scores indicate greater severity of depressive symptoms and therefore a worse outcome.

The Hamilton Anxiety Rating Scale (HAMA) consists of 14 items assessing psychological and somatic symptoms of anxiety. Each item is scored from 0 to 4, where 0 indicates no symptoms and 4 indicates very severe symptoms. The total score ranges from 0 to 56. Higher scores indicate greater severity of anxiety symptoms and therefore a worse outcome.

The keloid-specific quality of life questionnaire used in this study includes a Physical Domain consisting of five items assessing physical impairment related to keloids, including pain, pruritus, and limitations in daily activities. Each item is scored on a six-level scale using values of -5, -3, -1, 1, 3, and 5. The domain score is calculated as the arithmetic mean of the item scores and ranges from -5 to 5. Higher scores indicate greater physical impairment related to keloids and therefore a worse outcome.

The keloid-specific quality of life questionnaire used in this study includes a Psychological Domain consisting of nine items assessing the psychological and social impact of keloids, including embarrassment, self-image, concealment, social discomfort, and self-confidence. Each item is scored on a six-level scale using values of -5, -3, -1, 1, 3, and 5. The domain score is calculated as the arithmetic mean of the item scores and ranges from -5 to 5. Higher scores indicate greater psychological impairment related to keloids and therefore a worse outcome.