Clinical TrialID 8249
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
NCT05872854
Cutaneous T Cell Lymphoma|Mycosis Fungoides
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8249
- Evidence Id
- 8249
- Core Evidence Id
- 8249
- Source Clinical Trial Id
- 8247
- Herb2 Clinical Trial Id
- HBCT008247
- Nct Id
- NCT05872854
- Title
- Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Cutaneous T Cell Lymphoma|Mycosis Fungoides
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Hypericin|OTHER: Visible Light
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 50
- Outcome Measure
- Number of Treatment Responses of Index Lesions, A Treatment Response is defined as a ≥50% improvement in the Composite Assessment of Index Lesion Severity (CAILS) score score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the CAILS score at baseline. The CAILS score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome. The overall CAILS score is calculated by adding the total score as described above for each of the 3-5 index lesions. A lower score means a better outcome., Baseline up to 54 weeks
- Sponsor Collaborator
- Ellen Kim, MD|Soligenix
- Funded By
- OTHER
- Location
- Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, 19034, United States
- Other Id
- 05622 (UPCC)|RW-HPN-MF-01|851617
- Start Date
- 2023-08-21
- Primary Completion Date
- 2025-05-31
- Completion Date
- 2025-05-31
- First Posted
- 2023-05-24
- Results First Posted
- Last Update Posted
- 2024-07-29
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05872854
- Title Cn
- Title En
- Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
- Bilingual Status
- semi_complete