Use of aloevera in oral pruritic skin disease treatment

Recruiting

Conditions: Oral Lichenplanus

Registration Number: CTRI/2013/09/004029

Lead Sponsor: PMS College of Dental Sciences and research

Brief Summary: **Introduction:** Oral lichen planus[ OLP] is a chronic inflammatory mucocutaneous disease characterized by outbreaks or flares.1 It affects 0.2-1.9%of the population.2,3Although etiology is unknown, pathogenesis of oral lichenplanus is known to involve an immune disorder,with epithelial damage caused by cytotoxic CD8+lymphocytes1,2,3,4.The disease can produce considerable morbidity and alter patient quality of life,particularly in the presence of ulcerative lesions4,5. A variety of treatments have been proposed for Oral lichen planus:topical or systemic corticosteroids,cyclosporine,retinoids,azathioprine,tacrolimus, pimecrolimus,photochemotherapy and surgery4,5.The main inconvenience of these treatments is represented by the sideeffects they usually produce.3,4 Aloe vera(AV) (Aloe barbadensis miller) is a member of the liliaceae family6 It is widely used as a natural alternative therapy for various types of diseases, and several studies have suggested the healing ,cosmetic & nutritional benefits of this plant6 .Aloe vera exerts anti-inflammatory effects through the reduction of leucocyte adhesion &TNF- levels7,8,9 and the effect of topical aloe vera in Oral lichen planus has been studied and reported by Hayes 10 and Choonhakarn et al.11xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

**Objectives****:** To observe the efficacy of topical aloe vera in oral lichen planus by,

1) assessing the reduction in size of the lesion by clinical examination

2)assessing the reduction in burning sensation using visual analog scale

**Materials and Methods**: Patients who are diagnosed clinically and histopathologically as having oral lichen planus will be treated with topical aloe vera .Duration of this study will be approximately 1 yr from (june 2012- june 2013) Aloe vera gel will be used here which contains about 70% concentration of aloe vera .It is mainly the leaf pulp of this plant.Instructions should be given to relieve stress by patient councelling & reassuarance after informed consent.Biopsy will be done under local anesthesia in patients who are clinically diagnosed as having Oral Lichen planus in Department of Oral Medicine & Radiology .Pre treatment photographs will be taken as well as size of the lesion will be measured every week.Biopsy specimen will be send to the Department of Oral pathology & Microbiology for histopathological investigations.After confirming the diagnosis, treatment of Oral lichen planus will be carried out in Oral Medicine department by topical aloe vera preparation .Aloe vera gel of 70% concentration will be used [ from Hiran Agroceuticals Pvt Ltd, Madurai, India ].Duration of study/treatment is approximately 1yr.Method of application is topical by using a gauze spatula thrice daily for 12 weeks.It is allowed to remain in the mouth for 1 minute.After 1minute patient is asked to swish & spit.Patients will be reviewed on a weekly basis.On every recall visits size of lesion will be measured clinically which will be well supported by pre & post treatment photographs .Degree of burning sensation will be measured using the Visual analog scale.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients willing to undergo treatment and participate in the study.Patients clinically and histopathologically diagnosed with oral lichenplanus.

Exclusion Criteria

Patients above 70 yrs.
Pregnancy and lactating mothers.
Mentally challenged patients.
Allergic patients.
Patients taking drugs capable of producing lichenoid reactions.
Presence of dysplasia in histopathologic examination.
Patients with other dermatologic lesions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is measured as yes or no on the basis of reduction in size of the lesion clinically and by comparing pre and post treatment photographs. Assessing reduction in burning sensation/ pain using Visual Analog Scale	Patients are reviewed weekly for three months.

Secondary Outcome Measures

Name	Time	Method
There will be reduction in pain which will be assessed by the VAS.	Patients are reviewed weekly for 3 months and follow up for 6 months

Trial Locations

Locations (1): Dept. of Oral Medicine & Radiology Room No 1 PMS College of Dental Sciences
🇮🇳
Thiruvananthapuram, KERALA, India
Dept. of Oral Medicine & Radiology Room No 1 PMS College of Dental Sciences
🇮🇳Thiruvananthapuram, KERALA, India
Vivek V
Principal investigator
9447341035
vivekv@gmail.com