Clinical trial: Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients (NCT04278599)

Eligibility criteria:
Inclusion Criteria:

          1. Clinically and histopathologically proven cases of erosive and atrophic OLP.

          2. Patients who are willing to participate in the study.

        Exclusion Criteria:

          1. Patients with reticular form of OLP and OLP with muco-cutaneous involvement.

          2. Patients consuming drugs for the treatment of OLP in the past 6 months.

          3. Suspected lichenoid reaction associated with drugs and restorations.

          4. Patients whose histopathological findings indicate moderate to severe dysplasia.

          5. Patients with acquired and congenital immuno-deficiency disorders like AIDS,
             chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis.
             These patients are excluded because of difficulty in their biopsy procedure, control
             of infection, possible interaction with clinical findings of OLP, and their potential
             doubtful cooperation.

          6. Patients with systemic diseases involving the gastro-intestinal tract.

          7. Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption
             persists.

          8. Presence of factors that can alter the absorption of zinc like consumption of calcium
             tablets, iron supplements and high protein diet.

          9. Pregnancy and lactation phase

         10. Alcoholic patients, since alcoholism results in intracellular zinc deficiency.

         11. Recorded allergy to zinc and/or corticosteroids.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers



Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction