Pimecrolimus Ointment for Blepharitis

Recruiting at 28 trial locations

Overseen By Marian Macsai, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Famy Life Sciences, a Viatris Company

Disqualifiers: COVID, Herpetic keratitis, Neurotrophic keratitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

477 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.

Do I need to stop my current medications to join the trial?

The protocol does not specify if you need to stop your current medications. However, you cannot have received other treatments for blepharitis within 30 days of the first visit.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received other treatments for blepharitis within 30 days of the first visit.

What data supports the idea that Pimecrolimus Ointment for Blepharitis is an effective treatment?

The available research shows that Pimecrolimus cream is effective in treating atopic dermatitis, a skin condition similar to blepharitis. It helps reduce redness, itching, and swelling, and is well tolerated even on sensitive areas like the face. In studies, up to 70% of patients saw improvement in symptoms within three weeks. While there is no direct data on its use for blepharitis, its success in treating similar inflammatory skin conditions suggests it could be effective for blepharitis as well. ^{1 2 3 4 5}

What data supports the effectiveness of the drug pimecrolimus for treating blepharitis?

Pimecrolimus cream has been shown to be effective in treating atopic dermatitis, a skin condition, by reducing inflammation and preventing flare-ups. It is well tolerated and safe for use on sensitive areas like the face, which suggests it might also be effective for blepharitis, an inflammation of the eyelids. ^{1 2 3 4 5}

What safety data is available for Pimecrolimus (Elidel) treatment?

Pimecrolimus cream 1% (Elidel) has been shown to be minimally absorbed through the skin and generally well-tolerated, with the most common side effect being transient local skin reactions like burning. It may increase the risk of herpes simplex virus infections in children but does not increase the risk of other skin infections compared to corticosteroids. There is no clinical evidence linking it to an increased risk of malignancy. It is effective and safe for both short-term and long-term use in treating atopic dermatitis, with low systemic exposure even when applied to large body areas. ^{1 3 5 6 7}

Is pimecrolimus ointment safe for use in humans?

Pimecrolimus ointment, also known as Elidel, is generally safe for use in humans. It is minimally absorbed through the skin and is well tolerated, even on sensitive areas like the face and neck. The most common side effect is a temporary burning sensation on the skin, and while there is an increased risk of herpes simplex virus infections in children, it does not increase the risk of other skin infections or cause skin thinning like some other treatments. ^{1 3 5 6 7}

Is the drug Pimecrolimus (Elidel) a promising treatment for blepharitis?

Pimecrolimus (Elidel) is a promising treatment because it effectively reduces inflammation and symptoms like redness and itching in skin conditions. It is well-tolerated, even on sensitive areas, and helps prevent flare-ups, improving quality of life. ^{1 2 3 4 5}

How does the drug pimecrolimus ointment differ from other treatments for blepharitis?

Pimecrolimus ointment is unique because it is a non-steroid drug that inhibits inflammatory cytokines (proteins that can cause inflammation), and it has been effective in treating skin conditions like atopic dermatitis. Unlike traditional steroid treatments, it can be used on sensitive areas like the face and neck without significant side effects, making it potentially beneficial for blepharitis, which affects the eyelids. ^{1 2 3 4 5}

Research Team

Marian Macsai, MD

Principal Investigator

Viatris Eye Care Division

Eligibility Criteria

This trial is for people aged 2 years and older diagnosed with blepharitis, who haven't had success with lid hygiene. Participants need good vision, must be able to follow the study's rules including applying treatment twice daily, and women of childbearing age must test negative for pregnancy and use contraception. It excludes those recently treated for blepharitis or vaccinated/recovered from COVID-19 within a week before starting.

Inclusion Criteria

Be literate and able to complete questionnaires independently, or comprehend the questionnaires with the help of a parent/guardian or interviewer in the case of pediatric patients

I have given my consent verbally and in writing to participate.

Have a Corrected Distance Visual Acuity (CDVA) ≥ 0.7 logMar in each eye, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria

I haven't had treatments for blepharitis in the last 30 days.

Subjects unable to adhere to the study protocol

I got a COVID vaccine or recovered from COVID less than a week ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pimecrolimus 0.3% Ophthalmic Ointment or placebo for 6 weeks to evaluate efficacy and safety

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• Pimecrolimus

Trial Overview The trial is testing Pimecrolimus 0.3% Ophthalmic Ointment against a placebo ointment to see if it's effective and safe in treating blepharitis. Participants will apply one of these treatments without knowing which one they're using (blind study).

Participant Groups

Group I: Pimecrolimus 0.3% Ophthalmic Ointment Active Control 1 Intervention

Study Drug

Group II: Placebo Ophthalmic Ointment Placebo Group 1 Intervention

Placebo

Pimecrolimus is already approved in United States, European Union for the following indications:

Approved in United States as Elidel for:

• Mild to moderate atopic dermatitis (eczema) in non-immunocompromised adults and children 2 years of age and older

Approved in European Union as Elidel for:

• Mild to moderate atopic dermatitis (eczema) in non-immunocompromised adults and children 2 years of age and older

Who Is Running the Clinical Trial?

Famy Life Sciences, a Viatris Company

Lead Sponsor

Trials

1

Recruited

480+

Findings from Research

In a study involving 12 patients with chronic hand dermatitis, pimecrolimus cream 1% was applied twice daily and resulted in low blood concentrations of the drug, indicating minimal systemic absorption and a favorable safety profile.

The treatment was well tolerated with no serious adverse events, and 85% of subjects showed significant improvement in their condition by day 22, demonstrating its efficacy in managing chronic hand dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occlusive treatment of chronic hand dermatitis with pimecrolimus cream 1% results in low systemic exposure, is well tolerated, safe, and effective. An open study. Thaçi, D., Steinmeyer, K., Ebelin, ME., et al.[2017]

In a study of 192 adults with moderate to severe atopic dermatitis, pimecrolimus cream 1% significantly reduced the need for topical corticosteroids, with only 14.2% of treatment days requiring corticosteroids compared to 37.2% in the control group.

Pimecrolimus treatment led to a longer median time to first flare (144 days) and a higher percentage of patients (44.8%) remaining flare-free compared to the control group (18.8%), indicating its efficacy in managing atopic dermatitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Meurer, M., Fölster-Holst, R., Wozel, G., et al.[2017]

In a large study of 5,665 patients with atopic dermatitis, pimecrolimus ointment was found to be effective, with 79.3% of physicians and 76.5% of patients rating its efficacy as 'good'.

The treatment was well-tolerated, with 87.2% of physicians and 83.1% of patients reporting good tolerability, and it significantly improved quality of life for both children and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Post-marketing surveillance on treatment of 5,665 patients with atopic dermatitis using the calcineurin inhibitor pimecrolimus: positive effects on major symptoms of atopic dermatitis and on quality of life]. Sunderkötter, C., Weiss, JM., Bextermöller, R., et al.[2014]

Pimecrolimus cream is a new topical immunosuppressant approved for treating mild to moderate atopic dermatitis in patients aged 2 years and older, and it is the first in its class to be recommended for first-line use.

It can be used for both short-term treatment of inflamed skin and as a long-term preventive measure against flare-ups, with claims that it can reduce or eliminate the need for steroid treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream for atopic dermatitis. [2019]

Pimecrolimus cream 1% is effective in treating atopic eczema, providing rapid relief from itching and reducing redness and swelling in up to 70% of patients within the first three weeks of treatment.

It is well tolerated, even on sensitive skin areas like the face and neck, with low blood concentrations and no significant systemic side effects observed in both short- and long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. Graham-Brown, RA., Grassberger, M.[2014]

Pimecrolimus cream 1% is minimally absorbed through the skin and has a favorable safety profile, with the most common side effects being transient local reactions like skin burning.

While there is an increased risk of herpes simplex virus infections in children using pimecrolimus compared to a placebo, it does not increase the risk of skin infections compared to topical corticosteroids and does not cause corticosteroid-related side effects like skin atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance. Langley, RG., Luger, TA., Cork, MJ., et al.[2014]

In two 26-week clinical trials involving 403 children aged 2 to 17 with mild to moderate atopic dermatitis, pimecrolimus cream significantly improved parents' quality of life compared to a vehicle treatment, particularly noted at the 6-week mark.

While both groups showed improvements in quality of life over time, pimecrolimus demonstrated statistically significant superiority over the vehicle during the initial treatment phase, indicating its efficacy in managing pediatric atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parents' quality of life in the treatment of pediatric atopic dermatitis. Whalley, D., Huels, J., McKenna, SP., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Occlusive treatment of chronic hand dermatitis with pimecrolimus cream 1% results in low systemic exposure, is well tolerated, safe, and effective. An open study. [2017]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

[Post-marketing surveillance on treatment of 5,665 patients with atopic dermatitis using the calcineurin inhibitor pimecrolimus: positive effects on major symptoms of atopic dermatitis and on quality of life]. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream for atopic dermatitis. [2019]

5. India pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parents' quality of life in the treatment of pediatric atopic dermatitis. [2019]