Clinical trial NCT00746772: Efficacy of Purslane in Treatment of Oral Lichen Planus
Official title: Treatment of Oral Lichen Planus Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lichen Planus, Oral
Keywords: antioxidant
oral lichen planus
treatment
purslane
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 37
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral lichen planus (OLP) is a chronic inflammatory disease whose prevalence in the general population is 0.5 -2.2%.Oral lesions in OLP are chronic, rarely undergo spontaneous remission. Patients with OLP had significantly increased risk of oral squamous cell carcinoma, irrespective of the clinical type of OLP and therapy. there is currently no cure for OLP. Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids.DNA and proteins in lichen planus. This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction. Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties. The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.

Detailed description: Oral lichen planus is a chronic common inflammatory disorder affecting stratified squamous epithelia. The majority problem of OLP is development of oral squamous cell carcinoma , irrespective of the clinical type of OLP and therapy. Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids, DNA and proteins in lichen planus .This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction. So oxidative stress could be effective in pathogenesis of OLP. Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties. Purslane also decreased the level of TNF-α and IL6, that are responsible for up-regulated adhesion molecules (in OLP lymphocyte T (T cell) recruited and retained in sub mucosa through receptors to endothelial adhesion molecule. and basal keratinocytes undergo apoptosis). The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.

Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in combination with clinical appearance will be used for diagnosis
* Patients who had symptoms such as burning sensation, pain
* Patients not on any immunosuppressive or immunomodulatory treatment. In case they were,then such treatment should be stopped and a washout period of 1 month was given.
* Patients of both sexes between 30 to 70 year's old
* Patients who gave written informed consent
* Patients who were willing for evaluation in second week after therapy and every 1 month up to 6 months

Exclusion Criteria:

* The presence of histological signs of dysplasia
* Patients suffering from any localized or systemic disease
* Renal disease patients
* Pregnant patients
* Patients who can not continue the study for private or social reasons
* Patients who used lichenoid reaction including drugs

Primary outcomes:
measure: Relief sign &symptom and clinical features
timeFrame: (every 1 month up to 6months)
Secondary outcomes:
measure: Relief sign &symptom and clinical features
timeFrame: (time frame6 months)
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: farzaneh aghahosseini, professor
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: farzaneh aghahosseini, professor
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: hamidreza monsef esfehani, PHD
role: STUDY_DIRECTOR
affiliation: Qazvin University Of Medical Sciences
name: Katayun Borhanmojabi, DDS-MS
role: STUDY_DIRECTOR
affiliation: Qazvin University Of Medical Sciences
name: Shahroo Etemad moghadam, DDS-MS
role: STUDY_DIRECTOR
affiliation: Qazvin University Of Medical Sciences
name: Aida(touba) Karagah, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Eraj mirzaii, physiology
role: STUDY_DIRECTOR
References: