Afamelanotide in Patients Suffering With Acne Vulgaris

A Phase 2 study testing Afamelanotide in people with Acne Vulgaris, run by Clinuvel Pharmaceuticals Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 30 years, men only
Conditions the study is for: Acne Vulgaris
What is being tested?: Afamelanotide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: No sites listed yet
Study dates: 24 Aug 2010to 8 Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Men only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 13Show fewer

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.

About this study

Official title: A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris

Conditions: Acne Vulgaris
Being tested: Afamelanotide
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfamelanotideDrug
Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

Study groups in NCT04943159
Study group	Role	What they receive
Afamelanotide group A	Experimental	Not described Receives: Drug: Afamelanotide
Afamelanotide group B	Experimental	Not described Receives: Drug: Afamelanotide

What is being measured

The primary outcome is the main question the study is designed to answer.

The Change in Number of Facial Inflammatory Acne-related Lesions.
Measured: From baseline to Day 56.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 20108 Mar 2011

First posted29 Jun 2021
Study start24 Aug 2010
Primary completion8 Mar 2011
Study completion8 Mar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04943159
Sponsor's protocol ID: CUV100
Status last verified: Sep 2021
First submitted: 21 Jun 2021
Last updated: 26 Oct 2021
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris
ClinicalTrials.gov ID: NCT04943159
Acronym / sponsor ID: CUV100
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
Study start: 24 Aug 2010 (actual)
Primary completion: 8 Mar 2011 (actual)
Study completion: 8 Mar 2011 (actual)
First posted: 29 Jun 2021 (actual)
Results: Posted 26 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Afamelanotide group A	Experimental	Drug: Afamelanotide
Afamelanotide group B	Experimental	Drug: Afamelanotide

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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);

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AfamelanotideGroup A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.	Drug	Afamelanotide group A, Afamelanotide group B

Primary outcome

The Change in Number of Facial Inflammatory Acne-related Lesions.
Time frame: From baseline to Day 56.

Results and safety

Results posted to the registry on 26 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afamelanotide (Pooled Analysis)	3	3

Primary outcome: The Change in Number of Facial Inflammatory Acne-related Lesions.

Time frame: From baseline to Day 56.. Mean (Standard Error). Unit: Lesions

Measure	Afamelanotide (Pooled Analysis) n = 3
Baseline	46 (30.3)
Day 56	23.7 (15.6)

Population analysed: 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.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afamelanotide (Pooled Analysis)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afamelanotide in people with Acne Vulgaris, run by Clinuvel Pharmaceuticals Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change in Number of Facial Inflammatory Acne-related Lesions. (time frame: From baseline to Day 56.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04943159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.