Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment
18. juni 2026 opdateret af: Noor Aziz
Comparative Efficacy of Clobetasol 0.05% Versus Intralesional Triamcinolone in Treatment of Hypertrophic Lichen Planus at a Tertiary Care Hospital
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:
- Group A will apply a superpotent topical steroid cream (Clobetasol propionate 0.05%) to their lesions twice daily for 12 weeks.
- Group B will receive intralesional injections of a steroid medication (Triamcinolone acetonide 10 mg/mL) directly into the lesions once every 4 weeks for a total of four sessions over 12 weeks.
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Khyber Pakhtunkhua
-
Abbottabad, Khyber Pakhtunkhua, Pakistan, 21200
- Department of Dermatology, Combined Military Hospital (CMH)
-
Kontakt:
- Noor Aziz, MBBS, POST GRADUATE FELLOW
- Telefonnummer: +9233361571005
- E-mail: Nooraziz868@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age >= 18 years, both genders[cite: 1]
- Confirmed clinically as hypertrophic lichen planus with Lichen Planus Severity Index (LPSI) score >= 2 at baseline and Pruritus Visual Analog Scale (VAS) score >= 4 at baseline[cite: 1]
- No use of topical or intralesional treatment of lichen planus within the last 4 weeks[cite: 1]
- Able to provide written informed consent in English or Urdu language[cite: 1]
Exclusion Criteria:
- Drug-induced lichenoid lesions[cite: 1]
- Pregnant or lactating women[cite: 1]
- Uncontrolled diabetes mellitus or any other active skin infections[cite: 1]
- Necessity of systemic corticosteroids or immunosuppressive drugs as the primary treatment[cite: 1]
- Previous history of hypersensitivity or sensitivity to the study medicines (clobetasol propionate or triamcinolone acetonide)[cite: 1]
- Refusal to provide informed consent[cite: 1]
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Topical Clobetasol Propionate
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
|
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
|
|
Aktiv komparator: Intralesional Triamcinolone Acetonide
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
|
Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical outcome
Tidsramme: 12 weeks
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. april 2027
Studieafslutning (Anslået)
30. april 2027
Datoer for studieregistrering
Først indsendt
12. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Derma Cmh Abbottabad
Plan for individuelle deltagerdata (IPD)
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