The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (RCT)

Al-Azhar University

Status and phase: Completed; Phase 4

Conditions: Lichen Planus, Oral

Treatments: Drug: Tacrollimus Topical; Drug: Selenium; Drug: Triamcinolone Acetonide 0.1% Oint; Drug: Selenium & Triamcinolone Acetonide 0.1% Oint; Drug: Selenium& Tacrollimus topical

Study type: Interventional

Funder types: Other

Identifiers

NCT06362005

AUAREC2023011-1

Details and patient eligibility

About

evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

Full description

The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .

Enrollment: 50 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of OLP

Exclusion criteria

1. lichenoid reaction from medication ' .
2. any systemic autoimmune disease
3. Pregnancy
4. smokers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 5 patient groups, including a placebo group

group I (triamcinolone)

Placebo Comparator group

Description:

ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks.

Treatment:

Drug: Triamcinolone Acetonide 0.1% Oint

group II (tacrollimus)

Placebo Comparator group

Description:

ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.

Treatment:

Drug: Tacrollimus Topical

group III (selenium)

Experimental group

Description:

ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.

Treatment:

Drug: Selenium

group IV (selenium + triamcinolone )

Experimental group

Description:

: ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks

Treatment:

Drug: Selenium & Triamcinolone Acetonide 0.1% Oint

group V ( selenium + tacrollimus)

Experimental group

Description:

ten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks.

Treatment:

Drug: Selenium& Tacrollimus topical