Hypertrophic Lichen PlanusPhase 4NCT07666620
Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment
A Phase 4 study testing Clobetasol propionate 0.05% cream and Triamcinolone acetonide 10 mg/mL injection in people with Hypertrophic Lichen Planus, run by Noor Aziz at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Lichen Planus
- What is being tested?
- Clobetasol propionate 0.05% cream and Triamcinolone acetonide 10 mg/mL injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to 30 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Dermatology, Combined Military Hospital (CMH)
Abbottabad, Khyber Pakhtunkhua, 21200
Noor Aziz, MBBS, POST GRADUATE FELLOW, +9233361571005, Nooraziz868@gmail.com
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Hypertrophic Lichen Planus
- Being tested
- Clobetasol propionate 0.05% cream, Triamcinolone acetonide 10 mg/mL injection
- Keywords
- Clobetasol propionate, Triamcinolone acetonide, Intralesional injection, Topical corticosteroid, Lichenoid dermatosis, Hypertrophic skin lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol propionate 0.05% creamDrug
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
Triamcinolone acetonide 10 mg/mL injectionDrug
Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Clobetasol propionate 0.05% cream |
| 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 Receives: Drug: Triamcinolone acetonide 10 mg/mL injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noor Aziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noor Aziz, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666620
- Sponsor's protocol ID
- Derma Cmh Abbottabad
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39598213Sado 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.
PubMed 24511234Guo 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.
PubMed 34778301
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Clobetasol 0.05% Versus Intralesional Triamcinolone in Treatment of Hypertrophic Lichen Planus at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07666620
- Acronym / sponsor ID
- Derma Cmh Abbottabad
- Conditions
- Hypertrophic Lichen Planus
- Keywords
- Clobetasol propionate, Triamcinolone acetonide, Intralesional injection, Topical corticosteroid, Lichenoid dermatosis, Hypertrophic skin lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Noor AzizUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Clobetasol Propionate | Active comparator | Drug: Clobetasol propionate 0.05% creamSubjects 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 | Drug: Triamcinolone acetonide 10 mg/mL injectionSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (6 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasol propionate 0.05% creamSuperpotent topical corticosteroid cream applied twice daily for 12 weeks (p. 4). Patients are instructed to avoid washing the area for 30 minutes after application | Drug | Topical Clobetasol Propionate |
| Triamcinolone acetonide 10 mg/mL injectionCorticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12 | Drug | Intralesional Triamcinolone Acetonide |
Primary outcome
Clinical outcome
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 39598213Clim 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.
- Background: PubMed 24511234Sado 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.
- Background: PubMed 34778301Guo 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Dermatology, Combined Military Hospital (CMH)
Abbottabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clobetasol propionate 0.05% cream and Triamcinolone acetonide 10 mg/mL injection in people with Hypertrophic Lichen Planus, run by Noor Aziz at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07666620, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.