Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

NCT04219358 | Terminated Phase 1

• 1 other identifier: 2018-0656
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

Actinic cheilitis is a potentially malignant lesion on the lower lip, which can progress to more serious illnesses such as cancer if not treated. Usually treatment of this condition is only based on clinical appearance, but there is no established cure treatment. Topical imiquimod is a medicine indicated for the treatment of skin diseases, but it has not yet been proven to treat actinic cheilitis. In this research, the investigator's aim is to evaluate the response to actinic cheilitis treatment with the current standard treatment compared to high and low concentration imiquimod topical formulations.

Conditions

Actinic Cheilitis

Keywords

imiquimod; nanoencapsulation

Outcome Measures

Primary Outcomes (2)

• Clinical Response

  Clinical analysis of lip photographs based on a classification. The lesions will be graded as: AC Grade I. Dryness and desquamation on the vermilion of lips. AC Grade II. Atrophy on the vermilion's border, presenting soft surfaces and pallid areas with eruptions. Blurred limit between the lip's vermilion border and the skin, or a dark line demarking that limit can be seen. This melanotic line should be different from ephelides or other pigmented lesions. AC Grade III. Rough and squamous areas on the drier parts of the vermilion and hyperkeratotic areas, especially when they spread to the wet lip's mucosa (border between mucosa and semimucosa). AC Grade IV. Ulceration present in one or more sites of the lip's vermillion or Leukoplakia, mainly in more traumatic places, due to the history of pipe or cigarettes consumption. These lesions could suggest that a malignization process would be in progress, especially when they are accompanied by endured areas on palpation.

  30 days after conclusion of treatment

• Clinical Response

  Clinical analysis of lip photographs based on a classification. The lesions will be graded as: AC Grade I. Dryness and desquamation on the vermilion of lips. AC Grade II. Atrophy on the vermilion's border, presenting soft surfaces and pallid areas with eruptions. Blurred limit between the lip's vermilion border and the skin, or a dark line demarking that limit can be seen. This melanotic line should be different from ephelides or other pigmented lesions. AC Grade III. Rough and squamous areas on the drier parts of the vermilion and hyperkeratotic areas, especially when they spread to the wet lip's mucosa (border between mucosa and semimucosa). AC Grade IV. Ulceration present in one or more sites of the lip's vermillion or Leukoplakia, mainly in more traumatic places, due to the history of pipe or cigarettes consumption. These lesions could suggest that a malignization process would be in progress, especially when they are accompanied by endured areas on palpation.

  180 days after conclusion of treatment

Secondary Outcomes (17)

• General Satisfaction about the medication: Visual Analogue Scale (VAS)

  VAS scale will be generated at 14 days after beginning of the treatment.

• General Satisfaction about the medication: Visual Analogue Scale (VAS)

  VAS scale will be generated at 28 days after beginning of the treatment.

• General Satisfaction about the medication: Visual Analogue Scale (VAS)

  VAS scale will be generated at 60 days after beginning of the treatment.

• General Satisfaction about the medication: Visual Analogue Scale (VAS)

  VAS scale will be generated at 210 days after beginning of the treatment.

• Adverse Events Severity

  The adverse events questionnaire is applied in 14 days after beginning of the treatment.

Study Arms (4)

Placebo & Standard Treatment

ACTIVE COMPARATOR

Drug: Vehicle Gel Base; Drug: Lip sunscreen 30 Sun Protector Factor (SPF); Drug: Dexpanthenol

Imiquimod 5% & Standard Treatment

EXPERIMENTAL

Drug: Imiquimod 5% gel; Drug: Lip sunscreen 30 Sun Protector Factor (SPF); Drug: Dexpanthenol

Imiquimod 0.05% & Standard Treatment

EXPERIMENTAL

Drug: Imiquimod 0,05% gel; Drug: Lip sunscreen 30 Sun Protector Factor (SPF); Drug: Dexpanthenol

Imiquimod nanoencapsulated 0.05% & Standard Treatment

EXPERIMENTAL

Drug: Imiquimod nanoencapsulated 0,05% gel; Drug: Lip sunscreen 30 Sun Protector Factor (SPF); Drug: Dexpanthenol

Interventions

Vehicle Gel Base DRUG

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.

Placebo & Standard Treatment

Imiquimod 5% gel DRUG

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 5% & Standard Treatment

Imiquimod 0,05% gel DRUG

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 0.05% & Standard Treatment

Imiquimod nanoencapsulated 0,05% gel DRUG

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%

Imiquimod nanoencapsulated 0.05% & Standard Treatment

Lip sunscreen 30 Sun Protector Factor (SPF) DRUG

Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).

Imiquimod 0.05% & Standard Treatment; Imiquimod 5% & Standard Treatment; Imiquimod nanoencapsulated 0.05% & Standard Treatment; Placebo & Standard Treatment

Dexpanthenol DRUG

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 5% & Standard Treatment; Imiquimod nanoencapsulated 0.05% & Standard Treatment; Placebo & Standard Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with clinical and histopathological diagnosis of actinic cheilitis;
• No previous lip treatment with Imiquimod.

You may not qualify if:

• Present lesions suspected of squamous cell carcinoma of the lip.
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (2)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

School of Dentistry - Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

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MeSH Terms

Conditions

Actinic cheilitis

Interventions

Imiquimod; Gels; dexpanthenol

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Fernanda Visioli, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A pharmacist, who will not have contact with the study subjects at any time, will prepare the hydrogels in transparent sealed syringes, which will be numerically coded and two spreadsheets with the codes will be generated and placed in sealed brown envelopes. One envelope will be held by the pharmacist and the other envelope will be placed in a safe place. Participants will not know which medication they received until the end of the experimental phase. The vehicle gel is identical in appearance to those containing imiquimod. If for any reason the information on which treatment has been allocated is required, the external assistant will take all possible measures to ensure that the masking is not broken. The examiners who will perform the treatment and clinical evaluation will be blinded to the experimental group. Primary outcome measure is based on clinical evaluation of lesions by photographs. The images will be coded in order to achieve blindness of outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: January 7, 2020
• Study Start: March 23, 2019
• Primary Completion: June 24, 2020
• Study Completion: August 24, 2021
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)