Primary outcome· From Day 04 to Day 90
The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
| Group | Value |
|---|---|
| Afamelanotide | not posted |
| Placebo | not posted |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataAfamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
NCTNCT04425746 (opens ClinicalTrials.gov in a new tab)Other idCUV025
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 16 participants (actual)
- Sponsor
- Clinuvel Pharmaceuticals Limited · Industry
- Design
- Randomized · Quadruple masking
- Countries
- Not stated
- Start
- 5 Aug 2008
- Primary completion
- 28 May 2009
- Completion
- 28 May 2009
- First posted
- 11 Jun 2020
- Last update posted
- 1 Oct 2021
- Conditions
- Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 2
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
NCT044257465 Aug 2008 to 28 May 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.
Interventions
- AfamelanotideDrug
- PlaceboDrug
Arms2
Experimental
Afamelanotide
Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
Placebo comparator
Placebo
Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
Primary outcomes1
Outcomes the sponsor listed as primary.
The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
Time frame · From Day 04 to Day 90
Secondary outcomes(1)
Change in Quality of Life
Time frame · From Day 0 to Day 20, Day 60 and Day 90
Registry description
Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· From Day 0 to Day 20, Day 60 and Day 90
Change in Quality of Life
| Group | Value (Scores on a scale) |
|---|---|
| Afamelanotide | -5.7 |
| Placebo | 8.0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| AfamelanotideSubjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. Afamelanotide | – | 2 / 9 | 6 / 9 |
| PlaceboSubjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. Placebo | – | 3 / 7 | 1 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
* Aged greater than 18 years;
* Written informed consent prior to the performance of any study-specific procedure.
Exclusion Criteria:
* Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
* Non-Caucasian patients;
* Personal history of melanoma or dysplastic nevus syndrome;
* Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
* Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
* Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
* Patients unable to give informed consent;
* Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.
PepBank is a research reference. Talk to a doctor before you use any peptide.