Trial Outcomes & Findings for Afamelanotide in Patients Suffering With Acne Vulgaris (NCT NCT04943159)
NCT ID: NCT04943159
Last Updated: 2021-10-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From baseline to Day 56.
Results posted on
2021-10-26
Participant Flow
A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.
Participant milestones
| Measure |
Afamelanotide (Pooled Analysis)
* Group A are administered afamelanotide implant on Days 0, 21 and 42;
* Group B are administered afamelanotide implant on Days 0 and 28.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afamelanotide in Patients Suffering With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Afamelanotide (Pooled Analysis)
n=3 Participants
* Group A are administered afamelanotide implant on Days 0, 21 and 42;
* Group B are administered afamelanotide implant on Days 0 and 28.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 56.Population: A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.
Outcome measures
| Measure |
Afamelanotide (Pooled Analysis)
n=3 Participants
* Group A are administered afamelanotide implant on Days 0, 21 and 42;
* Group B are administered afamelanotide implant on Days 0 and 28.
|
|---|---|
|
The Change in Number of Facial Inflammatory Acne-related Lesions.
Baseline
|
46 Lesions
Standard Error 30.3
|
|
The Change in Number of Facial Inflammatory Acne-related Lesions.
Day 56
|
23.7 Lesions
Standard Error 15.6
|
Adverse Events
Afamelanotide (Pooled Analysis)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Afamelanotide (Pooled Analysis)
n=3 participants at risk
* Group A are administered afamelanotide implant on Days 0, 21 and 42;
* Group B are administered afamelanotide implant on Days 0 and 28.
|
|---|---|
|
General disorders
Fatigue
|
33.3%
1/3
A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place