ClinicalTrials.gg
RecruitingNCT06119672Updated Nov 7, 2023

Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

A Phase 3 interventional study of Probiotic Blend Oral capsules and Corticosteroids for Local Oral Treatment in Oral Lichen Planus, sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by October 6 University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled May 2023, registered Sep 2023).
  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 35 studies in Lichen Planus, Oral with a site in Egypt — 5 open to participants now, 7 under way, 2 of them phase 3. Lichen Planus, Oral · Egypt.

Planned enrollment
13th of 23
36 · median 39
Started
2023
with 9 others
Phase 3
3 of 35
1 open now
Registered
21st of 35
by date
Lead sponsor
2 of 35
October 6 University

Among the 35 studies in Lichen Planus, Oral with a site in Egypt, this one is the 13th largest by planned enrollment of the 23 interventional ones that give a count, is one of 10 that started in 2023, is one of 3 in phase 3, and was the 21st registered.

Lichen Planus, Oral

142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.

Browse Lichen Planus, Oral studies →

Open to participants now

5 of the 35 studies in Lichen Planus, Oral with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 14 Lichen Planus, Oral studies recruiting now, 10 (71%) set no upper age limit and 2 (14%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 20 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 35 studies in Lichen Planus, Oral with a site in Egypt, or all of them as a file.
02

Study summary

Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups

-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.

Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .

Patient's visits was at baseline, 2 weeks and 4 weeks.

03

Conditions studied

  • Oral Lichen Planus

Browse trials for

Keywords

  • oral lichen planus
  • probiotics
  • clobetasol probionate
04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
  • Male or female patient with age range between 20-75 years old were included.
  • medically free individuals

Exclusion criteria

Exclusion Criteria:

  • the use of systemic antibiotics, or agents within four weeks prior to enrollment in the study.
  • Pregnant females
  • patients with history of systemic disorder affecting the immune system
  • active liver diseases and cancer
  • allergy or intolerance to probiotics.
  • any other oral lesions
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    systemic probiotic (A)

    Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily

    Drug: Probiotic Blend Oral capsules · Drug: Corticosteroids for Local Oral Treatment

  • Active comparator
    topical corticosteroid (B)

    topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection

    Drug: Corticosteroids for Local Oral Treatment

Interventions

  • DrugProbiotic Blend Oral capsules

    probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily

  • DrugCorticosteroids for Local Oral Treatment

    topical clobetasol probionate in orabase application 4 times daily

    Also known as: clobetasol probionate in orabase

06

What researchers measure

Primary outcomes

  1. size wound

    thongprasom scale

    Time frame: 0 , 2 weeks and 4 weeks

  2. Pain in oral cavity

    Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain

    Time frame: 0 , 2 weeks and 4 weeks

Secondary outcomes

  1. candidal load assessment

    culturing technique in CFU unit

    Time frame: 0 and 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Oct 2023, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2023
First posted
Nov 7, 2023
StartActual
May 1, 2023
Primary completionEst.
Oct 30, 2023
CompletionEst.
Dec 30, 2023
Last update
Nov 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06119672
Collaborators
Cairo University
Responsible party
Amira Abdelwhab (lecturer, October 6 University) — Principal investigator
First posted
Nov 7, 2023
Start date
May 1, 2023
Primary completion
Oct 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Nov 7, 2023

Study contacts

Amira Abdelwhab, lecturer
Contact
amira.abdelwhab.dent@o6u.edu.eg
01007647877
yasmine kamal, lecturer
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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