Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis
NCT ID: NCT04219358
Last Updated: 2022-11-22
Study Results
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Basic Information
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TERMINATED
PHASE1
49 participants
INTERVENTIONAL
2019-03-23
2021-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo & Standard Treatment
Vehicle Gel Base
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and water.
Lip sunscreen 30 Sun Protector Factor (SPF)
Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
Dexpanthenol
Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon.
Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair.
Imiquimod 5% & Standard Treatment
Imiquimod 5% gel
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and free form imiquimod 5%.
Lip sunscreen 30 Sun Protector Factor (SPF)
Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
Dexpanthenol
Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon.
Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair.
Imiquimod 0.05% & Standard Treatment
Imiquimod 0,05% gel
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and imiquimod 0.05% free form.
Lip sunscreen 30 Sun Protector Factor (SPF)
Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
Dexpanthenol
Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon.
Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair.
Imiquimod nanoencapsulated 0.05% & Standard Treatment
Imiquimod nanoencapsulated 0,05% gel
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and imiquomod in a nanoencapsulated suspension at concentration of 0,05%
Lip sunscreen 30 Sun Protector Factor (SPF)
Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
Dexpanthenol
Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon.
Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair.
Interventions
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Vehicle Gel Base
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and water.
Imiquimod 5% gel
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and free form imiquimod 5%.
Imiquimod 0,05% gel
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and imiquimod 0.05% free form.
Imiquimod nanoencapsulated 0,05% gel
Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
Gel components: medium molecular weight chitosan, lactic acid 85% and imiquomod in a nanoencapsulated suspension at concentration of 0,05%
Lip sunscreen 30 Sun Protector Factor (SPF)
Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
Dexpanthenol
Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon.
Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair.
Eligibility Criteria
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Inclusion Criteria
* No previous lip treatment with Imiquimod.
Exclusion Criteria
* Previous history of lip cancer treatment.
* Prior treatment other than standard treatment.
* History of allergic reactions to imiquimod or any other component of the formulas.
18 Years
85 Years
ALL
Yes
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Fernanda Visioli, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Rio Grande do Sul
Locations
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Hospital de ClÃnicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
School of Dentistry - Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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References
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da Silva EL, Pedraca ES, Salgueiro AP, Gazzi RP, Nunes JS, Cavagni J, Martins MAT, Rados PV, Pohlmann AR, Guterres SS, Frank LA, Visioli F. Efficacy and safety of a 0.05 % nanoencapsulated imiquimod hydrogel for the treatment of actinic cheilitis: Drug release analysis and clinical study. Nanomedicine. 2024 Nov;62:102779. doi: 10.1016/j.nano.2024.102779. Epub 2024 Aug 14.
Other Identifiers
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2018-0656
Identifier Type: -
Identifier Source: org_study_id
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