Acne Vulgaris
Conditions
Brief summary
This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.
Interventions
DRUGAfamelanotide
Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.
Sponsors
Clinuvel Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3; * Chronic course of acne vulgaris; * Acne-related lesions both on the face, chest and back; * Indication for treatment of acne vulgaris; * Aged 18-30 years (inclusive); * Fitzpatrick skin types I-III; * Providing written Informed Consent prior to the performance of any study-specific procedure.
Exclusion criteria
* Female subjects; * Diagnosis of severe acne vulgaris; * Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant; * Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose; * Use of oral antibiotics for acne within 4 weeks prior to the first dose; * Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose; * Use of systemic retinoids within 6 months prior to the first dose; * Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose; * Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose; * Use of tanning booths or lamps within 1 week prior to the first dose; * Active skin disease that may interfere with evaluation; * Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne; * Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Change in Number of Facial Inflammatory Acne-related Lesions. | From baseline to Day 56. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Afamelanotide (Pooled Analysis) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
The Change in Number of Facial Inflammatory Acne-related Lesions.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afamelanotide (Pooled Analysis) | The Change in Number of Facial Inflammatory Acne-related Lesions. | Baseline | 46 Lesions | Standard Error 30.3 |
| Afamelanotide (Pooled Analysis) | The Change in Number of Facial Inflammatory Acne-related Lesions. | Day 56 | 23.7 Lesions | Standard Error 15.6 |