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. - Phase II Acne Vulgaris Pilot Study

• Register: EUCTR
• Last refreshed on: 3 December 2012
• Main ID: EUCTR2009-018024-15-DE
• Date of registration: 09/02/2010
• Prospective Registration: Yes
• Primary sponsor: Clinuvel Pharmaceuticals Limited
• Public 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. - Phase II Acne Vulgaris Pilot Study
• Scientific 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. - Phase II Acne Vulgaris Pilot Study
• Date of first enrolment: 27/05/2010
• Target sample size: 10
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018024-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Patients will be enrolled & randomised in equal numbers to one of two treatment groups. Refer D.3.5. If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: IMP

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
To be eligible to enter the study, patients must meet the following inclusion criteria:
- Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an 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;
- Agreeing to keep identical their shaving habits on the face during the entire study course; and
- Providing written Informed Consent prior to the performance of any study-specific procedure.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
To be eligible to enter the study, patients must not meet any of the following exclusion criteria:
- Female subjects;
- Diagnosis of severe acne vulgaris, defined as an IGA score of 4;
- Indication for treatment of acne vulgaris with isotretinoin therapy;
- Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anaesthetic 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 inhaled, intra-articular or intra-lesional (other than for facial, chest and back acne lesions) steroids is acceptable;
- 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(TM) or Zenozapper within 1 week prior to the first dose;
- Use of tanning booths or lamps within 1 week prior to the first dose;
- Use of the following types of products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild cleansers or moisturizers that contain retinol, salicylic acid or a- or ß-hydroxy acids for less than 2 weeks prior to the first dose;
- Have had the following types of procedures: chemical or laser peel, microdermabrasion or artificial UV therapy, performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks prior to the first dose;
- Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi;
- Any malignant or premalignant skin lesions;
- Active skin disease that may interfere with evaluation;
- Diagnosed with HIV/AIDS or hepatitis;
- Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator;
- History of systemic or psychiatric disease judged to be clinically significant by the Investigator;
- Acute history of drug or alcohol abuse in the last 12 months;
- Smoking;
- Patients who are expected to suffer from specific forms of severe stress such as university or other examinations, recent divorce, death and life-threatening illness of a family member or partner;
- Sexually active men with partners of childbearing potential not using barrier contraception during the trial and for a period of three months thereafter;
- Have been shaving their back and/or chest 4 weeks prior to the screening visit;
- Beard, moustache, sideburns (temporal zygomatic hair) or any other facial hair 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;
- History of significant post-inflammatory hyperpigmentation at the sites of acne lesions;
- History of keloid formation for subjects undergoing biopsies;
- Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit;
- Unwilling or failing to adhere to washout periods for specified treatments or procedures; and
- Patients assessed as not suita

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Acne vulgaris
MedDRA version: 12.1 Level: LLT Classification code 10000519 Term: Acne vulgaris

Intervention(s)

Product Name: Afamelanotide
Product Code: CUV1647
Pharmaceutical Form: Implant
INN or Proposed INN: Afamelanotide
CAS Number: 75921-69-6
Current Sponsor code: CUV1647
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-

Primary Outcome(s)

Main Objective: Primary objective:
- To determine the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris.

Primary end point(s): The primary efficacy endpoint of this study is:
The percent change in the facial inflammatory acne-related lesions count from baseline to Day 56. This will be done on polled data from Groups A and B.

H0: there will be no percent change in the facial inflammatory acne-related lesions count following afamelanotide treatment.

Secondary Objective: Secondary objectives:
- To determine the effect of afamelanotide on the facial total and non-inflammatory acne-related lesions in patients with mild to moderate acne vulgaris;
- To determine the effect of afamelanotide on the overall severity of acne in patients with mild to moderate acne vulgaris;
- To determine the effect of afamelanotide on inflammatory biomarkers (cytokines) in patients with mild to moderate acne vulgaris;
- To determine whether afamelanotide can improve the quality of life of patients with mild to moderate acne vulgaris;
- To compare the effect of two dosage regimens of afamelanotide in patients with mild to moderate acne vulgaris;
- To determine the effect of afamelanotide on skin melanin density in patients with mild to moderate acne vulgaris; and
- To determine the safety and tolerability of afamelanotide in patients with mild to moderate acne vulgaris.

Secondary ID(s)

CUV100