Trial · NCT04704713
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
NCT04704713, Phase 3, Completed, Clinuvel Pharmaceuticals Limited; results first posted 2021-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE). Trials, record NCT04704713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04704713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
- NCT number
- NCT04704713
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Conditions
- Polymorphic Light Eruption
- Interventions
- Afamelanotide, Placebo
- First posted
- 2021-01-12
- Last updated
- 2021-03-19
- Results first posted
- 2021-03-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale | From Day 0 to Day 120 | PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus). |
| Secondary | Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries | From Day 0 to Day 120 | |
| Secondary | Duration of PLE Episodes Recorded in Paper Patient Diaries | From Day 0 to Day 120 | |
| Secondary | Quality of Life Using the Dermatology Life Quality Index (DLQI) | At Day 0, Day 60 and Day 120 | The DLQI questionnaire consists of 10 questions, each answered on a categorical scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale | From Day 0 to Day 120 | score on a scale | MEDIAN | |
| SECONDARY | Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries | From Day 0 to Day 120 | |||
| SECONDARY | Duration of PLE Episodes Recorded in Paper Patient Diaries | From Day 0 to Day 120 | |||
| SECONDARY | Quality of Life Using the Dermatology Life Quality Index (DLQI) | At Day 0, Day 60 and Day 120 |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale | Afamelanotide | 0.25 | Full Range 0.0 to 1.4 | score on a scale | |
| Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale | Placebo | 0.47 | Full Range 0.0 to 4.1 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afamelanotide | 15 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | Afamelanotide | 11 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Afamelanotide | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | dizziness | Nervous system disorders | Afamelanotide | 1 | 15 | |
| other | dizziness | Nervous system disorders | Placebo | 0 | 16 | |
| other | Dysgeusia | Nervous system disorders | Afamelanotide | 1 | 15 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 0 | 16 | |
| other | Headache | Nervous system disorders | Afamelanotide | 4 | 15 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | Afamelanotide | 1 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 16 | |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Afamelanotide | 1 | 15 | |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Placebo | 0 | 16 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afamelanotide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Afamelanotide | 7 | 15 |
| Total, other adverse events | Placebo | 3 | 16 |
| Total, serious adverse events | Afamelanotide | 0 | 15 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Afamelanotide vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04704713
GET https://conductscience.org/api/trials/v1/NCT04704713/events?page=2