EUCTR2009-018024-15-DE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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