Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma

NCT ID: NCT02301494

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2023-04-30

Brief Summary

This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

Detailed Description

The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.

Conditions

Mycosis Fungoides

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluocinonide (Vanos) cream 0.1%

Fluocinonide (Vanos) cream 0.1% will be applied as currently approved by the FDA for treatment of corticosteroid responsive disorders of the skin. Treatment will continue for 4 months with a follow up at 6 and 12 months.

Group Type: EXPERIMENTAL

0.1% Fluocinonide Cream

Intervention Type: DRUG

CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.

3.75% Imiquimod (Zyclara) Cream

3.75% Imiquimod (Zyclara) Cream will be used as currently labeled by the FDA for treatment of actinic keratoses. Treatment will continue for 4 months with follow up at 6 and 12 months.

Group Type: EXPERIMENTAL

3.75% Imiquimod Cream

Intervention Type: DRUG

CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.

Interventions

3.75% Imiquimod Cream

CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.

Intervention Type: DRUG

0.1% Fluocinonide Cream

CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.

Intervention Type: DRUG

Other Intervention Names

Zyclara 3.75%; Vanos

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects aged ≥18 years.

2. Willing and able to give informed consent

3. Diagnosis of Mycosis Fungoides In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T-cell gamma gene rearrangement, as detected by PCR amplification and primer sets specific for the T-cell receptor gamma chain genes.

4. Subjects must have at least one target lesion

5. Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits.

6. Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate method of contraception (abstinence, condoms, hormonal therapy, barrier methods) during the study.

7. Patients must be otherwise healthy with an ECOG Performance status of 0 or 1.

8. The patient must not have had topical (2 weeks) or systemic therapy (4 weeks), radiotherapy (4 weeks) or phototherapy therapy (4 weeks) for Mycosis Fungoides within the stated number of weeks prior to start of treatment.

9. Eligible patients will be those who topical corticosteroid would be a preferred treatment and include patients newly diagnosed with stage IA, IB, or IIA disease, or those patients currently stable on therapy, in whom topical corticosteroids are being newly added to the regimen (i.e. recurrence or resistant lesions not currently treated with topical corticosteroids)

Exclusion Criteria

To be eligible for inclusion in this study the subjects must not meet any of the following criteria:

1. Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.

2. Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.

3. Received any investigational drug or taking part in any clinical study within one month prior to this study.

4. Known reaction or allergy to test drug or excipient.

5. Presence of major medical illness or symptoms of a clinically significant illness that may influence the study.

6. Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk such as a history of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol.

7. Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Rochester Skin Lymphoma Medical Group, PLLC

OTHER

Sponsor Role: collaborator

Rochester General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brian Poligone, MD, PhD

Scientist II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Poligone, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rochester General Hospital

References

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Reference Type: DERIVED

PMID: 32632956 (View on PubMed)

Other Identifiers

48861

Identifier Type: -

Identifier Source: org_study_id