- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219358
Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis
Evaluation of Topical Application of 5% Imiquimod, 0.05% Imiquimod and 0.05% Nanoencapsulated Imiquimod Gel in the Treatment of Actinic Cheilitis: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90040-060
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90040-060
- School of Dentistry - Universidade Federal do Rio Grande do Sul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals with clinical and histopathological diagnosis of actinic cheilitis;
- No previous lip treatment with Imiquimod.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Placebo & Standard Treatment
|
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.
Apply sunscreen on the lip 30 minutes every day before sun exposure.
Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
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. |
Experimental: Imiquimod 5% & Standard Treatment
|
Apply sunscreen on the lip 30 minutes every day before sun exposure.
Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
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. 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%. |
Experimental: Imiquimod 0.05% & Standard Treatment
|
Apply sunscreen on the lip 30 minutes every day before sun exposure.
Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
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. 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. |
Experimental: Imiquimod nanoencapsulated 0.05% & Standard Treatment
|
Apply sunscreen on the lip 30 minutes every day before sun exposure.
Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
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. 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% |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response
Time Frame: 30 days after conclusion of treatment
|
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
Time Frame: 180 days after conclusion of treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Satisfaction about the medication: Visual Analogue Scale (VAS)
Time Frame: VAS scale will be generated at 14 days after beginning of the treatment.
|
Satisfaction will be self-reported by VAS scale.
The visual analogue scale (VAS) will be used to measure general satisfaction of participants to treatment.
Participants will be asked to point in to a white paper with a 10cm line, where 0 represents none satisfaction and 10 maximum satisfaction.
|
VAS scale will be generated at 14 days after beginning of the treatment.
|
General Satisfaction about the medication: Visual Analogue Scale (VAS)
Time Frame: VAS scale will be generated at 28 days after beginning of the treatment.
|
Satisfaction will be self-reported by VAS scale.
The visual analogue scale (VAS) will be used to measure general satisfaction of participants to treatment.
Participants will be asked to point in to a white paper with a 10cm line, where 0 represents none satisfaction and 10 maximum satisfaction.
|
VAS scale will be generated at 28 days after beginning of the treatment.
|
General Satisfaction about the medication: Visual Analogue Scale (VAS)
Time Frame: VAS scale will be generated at 60 days after beginning of the treatment.
|
Satisfaction will be self-reported by VAS scale.
The visual analogue scale (VAS) will be used to measure general satisfaction of participants to treatment.
Participants will be asked to point in to a white paper with a 10cm line, where 0 represents none satisfaction and 10 maximum satisfaction.
|
VAS scale will be generated at 60 days after beginning of the treatment.
|
General Satisfaction about the medication: Visual Analogue Scale (VAS)
Time Frame: VAS scale will be generated at 210 days after beginning of the treatment.
|
Satisfaction will be self-reported by VAS scale.
The visual analogue scale (VAS) will be used to measure general satisfaction of participants to treatment.
Participants will be asked to point in to a white paper with a 10cm line, where 0 represents none satisfaction and 10 maximum satisfaction.
|
VAS scale will be generated at 210 days after beginning of the treatment.
|
Adverse Events Severity
Time Frame: The adverse events questionnaire is applied in 14 days after beginning of the treatment.
|
Adverse effects will be assessed during clinical evaluation at follow-up and with an adverse effects questionnaire.The questionnaire is based on self-reported events followed by a quantification of severity of local and systemic events.
The participants are asked to classify the events in a scale of 0 to 3. 0= no sympton, 1- mild, 2-moderate and 3-severe.
|
The adverse events questionnaire is applied in 14 days after beginning of the treatment.
|
Adverse Events Severity
Time Frame: The adverse events questionnaire is applied in 28 days after beginning of the treatment.
|
Adverse effects will be assessed during clinical evaluation at follow-up and with an adverse effects questionnaire.The questionnaire is based on self-reported events followed by a quantification of severity of local and systemic events.
The participants are asked to classify the events in a scale of 0 to 3. 0= no sympton, 1- mild, 2-moderate and 3-severe.
|
The adverse events questionnaire is applied in 28 days after beginning of the treatment.
|
Adverse Events Severity
Time Frame: The adverse events questionnaire is applied in 60 days after beginning of the treatment.
|
Adverse effects will be assessed during clinical evaluation at follow-up and with an adverse effects questionnaire.The questionnaire is based on self-reported events followed by a quantification of severity of local and systemic events.
The participants are asked to classify the events in a scale of 0 to 3. 0= no sympton, 1- mild, 2-moderate and 3-severe.
|
The adverse events questionnaire is applied in 60 days after beginning of the treatment.
|
Adverse Events Severity
Time Frame: The adverse events questionnaire is applied in 210 days after beginning of the treatment.
|
Adverse effects will be assessed during clinical evaluation at follow-up and with an adverse effects questionnaire.The questionnaire is based on self-reported events followed by a quantification of severity of local and systemic events.
The participants are asked to classify the events in a scale of 0 to 3. 0= no sympton, 1- mild, 2-moderate and 3-severe.
|
The adverse events questionnaire is applied in 210 days after beginning of the treatment.
|
Maturation epithelial pattern
Time Frame: Maturation epithelial pattern analysis will be performed at 28 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
With this examination it is possible to analyze morphological changes of the collected cells by light microscopy.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
From one of the obtained smears, Papanicolaou stain will be performed.
Papanicoloau staining allows assessing different cell types, which are quantified to evaluate epithelial differentiation.
|
Maturation epithelial pattern analysis will be performed at 28 days after beginning of the treatment.
|
Maturation epithelial pattern
Time Frame: Maturation epithelial pattern analysis will be performed at 60 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
With this examination it is possible to analyze morphological changes of the collected cells by light microscopy.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
From one of the obtained smears, Papanicolaou stain will be performed.
Papanicoloau staining allows assessing different cell types, which are quantified to evaluate epithelial differentiation.
|
Maturation epithelial pattern analysis will be performed at 60 days after beginning of the treatment.
|
Maturation epithelial pattern
Time Frame: Maturation epithelial pattern analysis will be performed at 210 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
With this examination it is possible to analyze morphological changes of the collected cells by light microscopy.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
From one of the obtained smears, Papanicolaou stain will be performed.
Papanicoloau staining allows assessing different cell types, which are quantified to evaluate epithelial differentiation.
|
Maturation epithelial pattern analysis will be performed at 210 days after beginning of the treatment.
|
Cell proliferation - mAgNOR
Time Frame: mAgNOR analysis will be performed at 28 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
One slide will be stained with AgNOR.
With this examination it is possible to analyze cell proliferation activity.
From the quantification of AgNORs, the average AgNORs / core (mAgNOR) will be calculated.
The low average of AgNOR stained cells indicates lower cell proliferation and a higher average indicates greater proliferation.
|
mAgNOR analysis will be performed at 28 days after beginning of the treatment.
|
Cell proliferation - mAgNOR
Time Frame: mAgNOR analysis will be performed at 60 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
One slide will be stained with AgNOR.
With this examination it is possible to analyze cell proliferation activity.
From the quantification of AgNORs, the average AgNORs / core (mAgNOR) will be calculated.
The low average of AgNOR stained cells indicates lower cell proliferation and a higher average indicates greater proliferation.
|
mAgNOR analysis will be performed at 60 days after beginning of the treatment.
|
Cell proliferation - mAgNOR
Time Frame: mAgNOR analysis will be performed at 210 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
One slide will be stained with AgNOR.
With this examination it is possible to analyze cell proliferation activity.
From the quantification of AgNORs, the average AgNORs / core (mAgNOR) will be calculated.
The low average of AgNOR stained cells indicates lower cell proliferation and a higher average indicates greater proliferation.
|
mAgNOR analysis will be performed at 210 days after beginning of the treatment.
|
Cell proliferation - pAgNOR
Time Frame: pAgNOR analysis will be performed at 28 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
One slide will be stained with AgNOR.
With this examination it is possible to analyze cell proliferation activity.
A second evaluation parameter will be the percentage of cells with more than 1, 2, 3 and 4 AgNORs / nucleus (pAgNOR).
A higher percentage of cells with more than 3 and 4 AgNORs per nucleus indicate greater proliferation.
|
pAgNOR analysis will be performed at 28 days after beginning of the treatment.
|
Cell proliferation - pAgNOR
Time Frame: pAgNOR analysis will be performed at 60 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
One slide will be stained with AgNOR.
With this examination it is possible to analyze cell proliferation activity.
A second evaluation parameter will be the percentage of cells with more than 1, 2, 3 and 4 AgNORs / nucleus (pAgNOR).
A higher percentage of cells with more than 3 and 4 AgNORs per nucleus indicate greater proliferation.
|
pAgNOR analysis will be performed at 60 days after beginning of the treatment.
|
Cell proliferation - pAgNOR
Time Frame: pAgNOR analysis will be performed at 210 days after beginning of the treatment.
|
Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology.
The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides.
One slide will be stained with AgNOR.
With this examination it is possible to analyze cell proliferation activity.
A second evaluation parameter will be the percentage of cells with more than 1, 2, 3 and 4 AgNORs / nucleus (pAgNOR).
A higher percentage of cells with more than 3 and 4 AgNORs per nucleus indicate greater proliferation.
|
pAgNOR analysis will be performed at 210 days after beginning of the treatment.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fernanda Visioli, PhD, Federal University of Rio Grande do Sul
Publications and helpful links
General Publications
- Poitevin NA, Rodrigues MS, Weigert KL, Macedo CLR, Dos Santos RB. Actinic cheilitis: proposition and reproducibility of a clinical criterion. BDJ Open. 2017 Aug 4;3:17016. doi: 10.1038/bdjopen.2017.16. eCollection 2017.
- Bernardi A, Frozza RL, Jager E, Figueiro F, Bavaresco L, Salbego C, Pohlmann AR, Guterres SS, Battastini AM. Selective cytotoxicity of indomethacin and indomethacin ethyl ester-loaded nanocapsules against glioma cell lines: an in vitro study. Eur J Pharmacol. 2008 May 31;586(1-3):24-34. doi: 10.1016/j.ejphar.2008.02.026. Epub 2008 Feb 19.
- Bernardi A, Zilberstein AC, Jager E, Campos MM, Morrone FB, Calixto JB, Pohlmann AR, Guterres SS, Battastini AM. Effects of indomethacin-loaded nanocapsules in experimental models of inflammation in rats. Br J Pharmacol. 2009 Oct;158(4):1104-11. doi: 10.1111/j.1476-5381.2009.00244.x. Epub 2009 May 6.
- Bernardi A, Braganhol E, Jager E, Figueiro F, Edelweiss MI, Pohlmann AR, Guterres SS, Battastini AM. Indomethacin-loaded nanocapsules treatment reduces in vivo glioblastoma growth in a rat glioma model. Cancer Lett. 2009 Aug 18;281(1):53-63. doi: 10.1016/j.canlet.2009.02.018. Epub 2009 Mar 14.
- Swanson N, Abramovits W, Berman B, Kulp J, Rigel DS, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):582-90. doi: 10.1016/j.jaad.2009.07.004. Epub 2010 Feb 4.
- Sotiriou E, Lallas A, Goussi C, Apalla Z, Trigoni A, Chovarda E, Ioannides D. Sequential use of photodynamic therapy and imiquimod 5% cream for the treatment of actinic cheilitis: a 12-month follow-up study. Br J Dermatol. 2011 Oct;165(4):888-92. doi: 10.1111/j.1365-2133.2011.10478.x. Epub 2011 Sep 15.
- Smith KJ, Germain M, Yeager J, Skelton H. Topical 5% imiquimod for the therapy of actinic cheilitis. J Am Acad Dermatol. 2002 Oct;47(4):497-501. doi: 10.1067/mjd.2002.126266.
- McDonald C, Laverick S, Fleming CJ, White SJ. Treatment of actinic cheilitis with imiquimod 5% and a retractor on the lower lip: clinical and histological outcomes in 5 patients. Br J Oral Maxillofac Surg. 2010 Sep;48(6):473-6. doi: 10.1016/j.bjoms.2009.08.024.
- Manganaro AM, Will MJ, Poulos E. Actinic cheilitis: a premalignant condition. Gen Dent. 1997 Sep-Oct;45(5):492-4.
- Lundeen RC, Langlais RP, Terezhalmy GT. Sunscreen protection for lip mucosa: a review and update. J Am Dent Assoc. 1985 Oct;111(4):617-21. doi: 10.14219/jada.archive.1985.0157.
- Lebwohl M, Dinehart S, Whiting D, Lee PK, Tawfik N, Jorizzo J, Lee JH, Fox TL. Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. J Am Acad Dermatol. 2004 May;50(5):714-21. doi: 10.1016/j.jaad.2003.12.010.
- Krawtchenko N, Roewert-Huber J, Ulrich M, Mann I, Sterry W, Stockfleth E. A randomised study of topical 5% imiquimod vs. topical 5-fluorouracil vs. cryosurgery in immunocompetent patients with actinic keratoses: a comparison of clinical and histological outcomes including 1-year follow-up. Br J Dermatol. 2007 Dec;157 Suppl 2:34-40. doi: 10.1111/j.1365-2133.2007.08271.x.
- Kopera D, Kerl H. Visualization and treatment of subclinical actinic keratoses with topical imiquimod 5% cream: an observational study. Biomed Res Int. 2014;2014:135916. doi: 10.1155/2014/135916. Epub 2014 May 11.
- Kaugars GE, Pillion T, Svirsky JA, Page DG, Burns JC, Abbey LM. Actinic cheilitis: a review of 152 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Aug;88(2):181-6. doi: 10.1016/s1079-2104(99)70115-0.
- Jorizzo J, Dinehart S, Matheson R, Moore JK, Ling M, Fox TL, McRae S, Fielder S, Lee JH. Vehicle-controlled, double-blind, randomized study of imiquimod 5% cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head. J Am Acad Dermatol. 2007 Aug;57(2):265-8. doi: 10.1016/j.jaad.2007.01.047. Epub 2007 May 18.
- Greenberg HL, Cohen JL, Rosen T, Orengo I. Severe reaction to 5% imiquimod cream with excellent clinical and cosmetic outcomes. J Drugs Dermatol. 2007 Apr;6(4):452-8.
- Gebauer K, Shumack S, Cowen PS. Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial. Br J Dermatol. 2009 Oct;161(4):897-903. doi: 10.1111/j.1365-2133.2009.09260.x. Epub 2009 May 26.
- A Gaspari A, Tyring SK, Rosen T. Beyond a decade of 5% imiquimod topical therapy. J Drugs Dermatol. 2009 May;8(5):467-74.
- Frank LA, Chaves PS, D'Amore CM, Contri RV, Frank AG, Beck RC, Pohlmann AR, Buffon A, Guterres SS. The use of chitosan as cationic coating or gel vehicle for polymeric nanocapsules: Increasing penetration and adhesion of imiquimod in vaginal tissue. Eur J Pharm Biopharm. 2017 May;114:202-212. doi: 10.1016/j.ejpb.2017.01.021. Epub 2017 Feb 1.
- Frank LA, Sandri G, D'Autilia F, Contri RV, Bonferoni MC, Caramella C, Frank AG, Pohlmann AR, Guterres SS. Chitosan gel containing polymeric nanocapsules: a new formulation for vaginal drug delivery. Int J Nanomedicine. 2014 Jun 28;9:3151-61. doi: 10.2147/IJN.S62599. eCollection 2014.
- Ferreira AM, de Souza Lucena EE, de Oliveira TC, da Silveira E, de Oliveira PT, de Lima KC. Prevalence and factors associated with oral potentially malignant disorders in Brazil's rural workers. Oral Dis. 2016 Sep;22(6):536-42. doi: 10.1111/odi.12488. Epub 2016 May 17.
- Falagas ME, Angelousi AG, Peppas G. Imiquimod for the treatment of actinic keratosis: A meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2006 Sep;55(3):537-8. doi: 10.1016/j.jaad.2006.05.030. No abstract available.
- Eigentler TK, Kamin A, Weide BM, Breuninger H, Caroli UM, Mohrle M, Radny P, Garbe C. A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma. J Am Acad Dermatol. 2007 Oct;57(4):616-21. doi: 10.1016/j.jaad.2007.05.022. Epub 2007 Jul 3.
- Dufresne RG Jr, Curlin MU. Actinic cheilitis. A treatment review. Dermatol Surg. 1997 Jan;23(1):15-21.
- dos Santos LR, Cernea CR, Kowalski LP, Carneiro PC, Soto MN, Nishio S, Hojaij FC, Dutra Junior A, Britto e Silva Filho G, Ferraz AR. Squamous-cell carcinoma of the lower lip: a retrospective study of 58 patients. Sao Paulo Med J. 1996 Mar-Apr;114(2):1117-26. doi: 10.1590/s1516-31801996000200003.
- Daniel FI, Alves SR, Vieira DS, Biz MT, Daniel IW, Modolo F. Immunohistochemical expression of DNA methyltransferases 1, 3a, and 3b in actinic cheilitis and lip squamous cell carcinomas. J Oral Pathol Med. 2016 Nov;45(10):774-779. doi: 10.1111/jop.12453. Epub 2016 May 9.
- de Souza Lucena EE, Costa DC, da Silveira EJ, Lima KC. Prevalence and factors associated to actinic cheilitis in beach workers. Oral Dis. 2012 Sep;18(6):575-9. doi: 10.1111/j.1601-0825.2012.01910.x. Epub 2012 Feb 15.
- Contri RV, Katzer T, Ourique AF, da Silva AL, Beck RC, Pohlmann AR, Guterres SS. Combined effect of polymeric nanocapsules and chitosan hydrogel on the increase of capsaicinoids adhesion to the skin surface. J Biomed Nanotechnol. 2014 May;10(5):820-30. doi: 10.1166/jbn.2014.1752.
- Couvreur P, Barratt G, Fattal E, Legrand P, Vauthier C. Nanocapsule technology: a review. Crit Rev Ther Drug Carrier Syst. 2002;19(2):99-134. doi: 10.1615/critrevtherdrugcarriersyst.v19.i2.10.
- Contri RV, Frank LA, Kaiser M, Pohlmann AR, Guterres SS. The use of nanoencapsulation to decrease human skin irritation caused by capsaicinoids. Int J Nanomedicine. 2014 Feb 12;9:951-62. doi: 10.2147/IJN.S56579. eCollection 2014.
- Cavalcante AS, Anbinder AL, Carvalho YR. Actinic cheilitis: clinical and histological features. J Oral Maxillofac Surg. 2008 Mar;66(3):498-503. doi: 10.1016/j.joms.2006.09.016.
- Cataldo E, Doku HC. Solar cheilitis. J Dermatol Surg Oncol. 1981 Dec;7(12):989-95. doi: 10.1111/j.1524-4725.1981.tb00203.x.
- Bulcao RP, Freitas FA, Venturini CG, Dallegrave E, Durgante J, Goethel G, Cerski CT, Zielinsky P, Pohlmann AR, Guterres SS, Garcia SC. Acute and subchronic toxicity evaluation of poly(epsilon-caprolactone) lipid-core nanocapsules in rats. Toxicol Sci. 2013 Mar;132(1):162-76. doi: 10.1093/toxsci/kfs334. Epub 2012 Dec 12.
- Bulcao RP, de Freitas FA, Dallegrave E, Venturini CG, Baierle M, Durgante J, Sauer E, Cassini C, Cerski CT, Zielinsky P, Salvador M, Pohlmann AR, Guterres SS, Garcia SC. In vivo toxicological evaluation of polymeric nanocapsules after intradermal administration. Eur J Pharm Biopharm. 2014 Feb;86(2):167-77. doi: 10.1016/j.ejpb.2013.04.001. Epub 2013 May 2.
- Spyridonos P, Gaitanis G, Tzaphlidou M, Bassukas ID. Spatial fuzzy c-means algorithm with adaptive fuzzy exponent selection for robust vermilion border detection in healthy and diseased lower lips. Comput Methods Programs Biomed. 2014 May;114(3):291-301. doi: 10.1016/j.cmpb.2014.02.017. Epub 2014 Mar 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0656
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Actinic Cheilitis
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-
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Dong-A UniversityCompletedActinic CheilitisKorea, Republic of
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Tufts Medical CenterDUSA Pharmaceuticals, Inc.CompletedActinic Cheilitis | Squamous Cell Carcinoma In-situ (SCC-is) | Squamous Cell Carcinoma (SCC) | Photodynamic Therapy (PDT) | Mohs SurgeryUnited States
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University of PalermoRecruitingOral Disease | Oral Cancer | Actinic Keratoses | Oral Leukoplakia | Oral Squamous Cell Carcinoma | Oral Lichen Planus | Graft-versus-host-disease | Proliferative Verrucous Leukoplakia | Actinic Cheilitis | Oral Potentially Malignant Disorder | Oral Erythroplakia | Oral Lichenoid LesionItaly
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Cosmetique Active InternationalNot yet recruiting
Clinical Trials on Vehicle Gel Base
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University of British ColumbiaUnknownCicatrix | Scar | Keloid | Hypertrophic Scar | Skin Graft Scar | Skin Graft Complications | Donor Site ComplicationCanada
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NFlection Therapeutics, Inc.CompletedNeurofibromatosis 1 | Cutaneous NeurofibromaUnited States
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NFlection Therapeutics, Inc.CompletedNeurofibromatosis 1 | Cutaneous NeurofibromaUnited States
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LEO PharmaCompletedActinic KeratosisUnited States
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BioMendics, LLCCompletedEpidermolysis Bullosa SimplexUnited States
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BioMendics, LLCSymbio, LLCCompletedWound HealingUnited States
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Novan, Inc.CompletedAcne VulgarisUnited States
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LEO PharmaCompletedActinic KeratosisUnited States
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Galderma R&DCompleted
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G&E Herbal Biotechnology Co., LTDCompletedActinic KeratosisTaiwan