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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05380635
Other study ID # HPN-CTCL-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 9, 2022
Est. completion date August 16, 2022

Study information

Verified date May 2023
Source Soligenix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date August 16, 2022
Est. primary completion date August 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA - CTCL lesions covering = 10% of their body surface area Exclusion Criteria: - History of allergy or hypersensitivity to any of the components of HyBryte - Pregnancy or mothers who are breast-feeding - Males and females not willing to use effective contraception - Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.) - Subjects whose condition is spontaneously improving - Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment - Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment - Subjects who have received electron beam irradiation within 3 months of enrollment - Subjects with a history of significant systemic immunosuppression - Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment - Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hypericin
HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Locations

Country Name City State
United States Rochester Skin Lymphoma Medical Group Fairport New York

Sponsors (1)

Lead Sponsor Collaborator
Soligenix

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electrocardiograms (ECG) Assess any ECG QT interval changes (defined as any occurrences of QT interval >500 ms or changes in QT interval >60 ms) during standard HyBryte photodynamic therapy. 10 weeks
Primary Systemic Blood Levels Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy. 10 weeks
Secondary Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a =50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. A treatment response was defined as a =50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline.
The Composite Assessment of Index Lesion Disease Severity (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 was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.
10 weeks
Secondary Number of Index Lesions With a Treatment Response as Defined as a =50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. A treatment response was defined as a =50% improvement in CAILS score at Week 10 when compared to the CAILS score at baseline in each of the individual Index Lesions.
The Composite Assessment of Index Lesion Disease Severity (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.
10 weeks
Secondary Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. A complete response was defined as a 100% improvement in CAILS score (a CAILS score of 0) at Week 10 in each of the individual Index Lesions.
The Composite Assessment of Index Lesion Disease Severity (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.
10 weeks
See also
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Recruiting NCT06436677 - A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
Completed NCT04702503 - Study of WP1220 for the Treatment of Adult Subjects With Cutaneous T-Cell Lymphoma (CTCL) Phase 1
Not yet recruiting NCT06113081 - Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma
Recruiting NCT06149247 - HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL Phase 2
Terminated NCT03713320 - SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides Phase 2