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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

NCTNCT04704713 (opens ClinicalTrials.gov in a new tab)Other idCUV032
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
31 participants (actual)
Sponsor
Clinuvel Pharmaceuticals Limited · Industry
Design
Randomized · Quadruple masking
Countries
Not stated
Start
5 May 2010
Primary completion
9 Dec 2010
Completion
Not stated
First posted
12 Jan 2021
Last update posted
19 Mar 2021
Conditions
Polymorphic Light Eruption

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011
  1. Ph 3

    Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

    NCT04704713

    5 May 2010 to 9 Dec 2010 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).

Interventions

  • AfamelanotideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Afamelanotide

    Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.

  • Placebo comparator

    Placebo

    Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale

    Time frame · From Day 0 to Day 120

    Registry description

    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 outcomes(3)

  1. Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries

    Time frame · From Day 0 to Day 120

  2. Duration of PLE Episodes Recorded in Paper Patient Diaries

    Time frame · From Day 0 to Day 120

  3. Quality of Life Using the Dermatology Life Quality Index (DLQI)

    Time frame · At Day 0, Day 60 and Day 120

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· From Day 0 to Day 120

Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale

GroupValue (score on a scale)
Afamelanotide0.25
Placebo0.47
Secondary and other outcome results(3)
Secondary outcome· From Day 0 to Day 120

Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries

GroupValue
Secondary outcome· From Day 0 to Day 120

Duration of PLE Episodes Recorded in Paper Patient Diaries

GroupValue
Secondary outcome· At Day 0, Day 60 and Day 120

Quality of Life Using the Dermatology Life Quality Index (DLQI)

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AfamelanotideAfamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Afamelanotide–0 / 157 / 15
PlaceboPlacebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Placebo–0 / 163 / 16

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: * Aged greater than 18 years * Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms. * Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates) * Written informed consent prior to the performance of any study-specific procedure * Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator Exclusion Criteria: * Currently requiring treatment with systemic immunosuppressive agents * Documented history of other photosensitivity conditions which may be confused with PLE or interfere with the assessment of PLE episodes * Solarium use in the three months prior to study involvement and throughout the duration of the study * Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the Investigator may interfere with this study * Documented presence (\> 1 in 320) of Anti-Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available * In the opinion of the Investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters * History of drug or alcohol abuse (in the last 1 year) * Female who is pregnant (confirmed by positive serum beta-Human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating * Female of child-bearing potential (pre-menopausal, not surgically sterile) that is not using or is not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device) * Sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months thereafter * Participation in a clinical trial with another Investigational Medicinal Product (IMP) within 30 days prior to the Screening visit or during the study * Hypersensitivity to afamelanotide or any of its components

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