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The purpose of this study is to compare the efficacy and safety of two standard corticosteroid treatments for hypertrophic lichen planus (HLP), a chronic inflammatory skin condition that causes thick, intensely itchy plaques.
Patients participating in the study will be randomly assigned to one of two treatment groups:
The primary objective is to determine which approach achieves a better reduction in plaque thickness and severity using the Lichen Planus Severity Index (LPSI) score at week 12. The study will also track changes in itching severity using a Visual Analog Scale (VAS), changes in overall lesion surface area, and monitor for any local side effects such as skin thinning or pigment changes.
This is a randomized, single-blind (outcome assessor blinded), parallel-group clinical trial conducted at the Department of Dermatology, Combined Military Hospital, Abbottabad, Pakistan. A total of 116 eligible participants (58 per group) aged 18 and older with a confirmed diagnosis of hypertrophic lichen planus will be enrolled via consecutive sampling. Group A will receive topical Clobetasol propionate 0.05% cream twice daily for 12 weeks. Group B will receive intralesional Triamcinolone acetonide (10 mg/mL, 0.1-0.2 mL per site spaced 1 cm apart, max 0.5 mL/cm²) at weeks 0, 4, 8, and 12. Outcome parameters (LPSI, pruritus VAS, and lesion area in cm²) will be recorded at baseline, week 4, week 8, and week 12 to statistically evaluate and compare clinical response rates and the incidence of adverse drug reactions between the two treatment modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Clobetasol Propionate | Active Comparator | Subjects will apply superpotent topical clobetasol propionate 0.05% cream in a thin film to the affected lesion twice daily (morning and night) for a total duration of 12 weeks |
|
| Intralesional Triamcinolone Acetonide | Active Comparator | Subjects will receive 10 mg/mL of triamcinolone acetonide injected intralesionally using a 26-gauge needle. The dose will be 0.1-0.2 mL per site separated by 1 cm, with a maximum volume of 0.5 mL/cm² of lesion size. Injections will be given during weeks 0, 4, 8, and 12 (total of 4 sessions over 12 weeks) (p. 4). Topical lidocaine 2% gel will be applied 5 minutes before injection for local anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol propionate 0.05% cream | Drug | Superpotent topical corticosteroid cream applied twice daily for 12 weeks (p. 4). Patients are instructed to avoid washing the area for 30 minutes after application |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | The Lichen Planus Severity Index (LPSI) is a clinical scoring system used to evaluate the severity of hypertrophic lichen planus lesions based on physical characteristics (such as plaque thickness, elevation, and hyperkeratosis). The score ranges from 0 to 4, where a score of 0 indicates complete flattening/resolution of plaques, and higher scores represent increased lesion severity. Clinical response at 12 weeks will be categorized based on the reduction from baseline: Complete Response (LPSI = 0), Good Response (>= 2-point reduction), Partial Response (1-point reduction), and No Response (no reduction or worsening). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Combined Military Hospital (CMH) | Abbottabad | Khyber Pakhtunkhua | 21200 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39598213 | Background | Clim A, Maranduca MA, Filip N, Tanase DM, Floria M, Pinzariu AC, Popa IP, Nemteanu R, Cozma TC, Faur FI, Serban DN, Scripcariu DV, Serban IL. The Influence of Atorvastatin Treatment on Homocysteine Metabolism and Oxidative Stress in an Experimental Model of Diabetic Rats. Life (Basel). 2024 Nov 2;14(11):1414. doi: 10.3390/life14111414. | |
| 24511234 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jun 18, 2026 | Jun 18, 2026 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| D014222 | Triamcinolone Acetonide |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Triamcinolone acetonide 10 mg/mL injection | Drug | Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12 |
|
| Sado M, Shirahase J, Yoshimura K, Miura Y, Yamamoto K, Tabuchi H, Kato M, Mimura M. Predictors of repeated sick leave in the workplace because of mental disorders. Neuropsychiatr Dis Treat. 2014 Jan 29;10:193-200. doi: 10.2147/NDT.S55490. eCollection 2014. |
| 34778301 | Background | Guo L, Zhang H, Liu P, Mi T, Ha D, Su L, Huang L, Shi Y, Zhang J. Preclinical Assessment of Paclitaxel- and Trastuzumab-Delivering Magnetic Nanoparticles Fe3O4 for Treatment and Imaging of HER2-Positive Breast Cancer. Front Med (Lausanne). 2021 Oct 28;8:738775. doi: 10.3389/fmed.2021.738775. eCollection 2021. |
| D011083 |
| Polycyclic Compounds |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |