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Spots Global Cancer Trial Database for REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

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Trial Identification

Brief Title: REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

Official Title: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

Study ID: NCT04218825

Interventions

chlormethine gel

Study Description

Brief Summary: Adult patients with early stage MF-CTCL (stage IA-IB) will be eligible for this study. A total of 100 early stage MF-CTCL patients diagnosed in the past year will be enrolled. Treatment with CL gel will be applied once daily to all skin areas affected by MF-CTCL and, for 8 weeks, one selected skin area unaffected by MF-CTCL (0.5% body surface area) until treatment response (complete response), study treatment duration completed (56 weeks), progression, or another withdrawal criterion is met. Depending on the type of skin drug-related reaction (if any) occurring after application of CL gel, this study will categorize patients into three different groups corresponding to three different treatment patterns: * Group A: Patients with no skin drug reaction with CL gel application * Group B: Patients developing a skin drug reaction of any grade with CL gel application, not due to allergic reaction to CL gel, will continue treatment at reduced application frequency * Group C: Patients from Group B unable to tolerate reduced CL gel application frequency will apply a potent topical steroid twice daily in addition to CL gel applied every other day

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre, Bordeaux, , France

Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis, Paris, , France

Contact Details

Name: Julia Scarisbrick, MD

Affiliation: UHB-Queen Elisabeth Medical Centre, Birmingham, United Kingdom

Role: STUDY_CHAIR

Name: Emmanuella Guenova, MD

Affiliation: Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, Switzerland

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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