A double-blind, randomised, parallel group, placebo-controlled dose finding Phase II study to compare the efficacy and safety of topically applied Avugane™ of different concentrations in subjects with mild to moderate acne vulgaris

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

1. Clinically confirmed diagnosis of facial acne papulopustulosa or acne
papulopustulosa et comedonica with a mild to moderate intensity (grade 2 to 8
according to the revised Leeds Scale of Acne Grading13) and with at least 12
inflammatory lesions
2. Patients aged between 18 and 40
3. A general good health condition as confirmed by a physical examination and by
medical history
4. Acceptance of oil-free skin care products
5. Acceptance to abstain from any other systemic or topical acne treatment during trial
6. Acceptance to abstain from sun bathing and the solarium
7. Signed informed consent

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

1. Females with positive pregnancy test at baseline
2. Females of childbearing potential without using a safe contraceptive measure (e.g.
pill, IUD, gestagen depot injection, subdermal implant, hormonal vaginal ring,
transdermal depot patch), nursing women
3. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne,
cosmetic induced acne
4. Localisation of acne that requires treatment predominantly on the chest and/or the
back
5. Patients with a personal or family history of cutaneous epithelioma
6. History or presence of disorders commonly accepted as contraindications to the
treatment with 2-propylpentanoic acid (2-PPA):
A.Evidence in the subject's and family medical history of liver diseases or apparent
severe functional disorders of liver and pancreas
B.Functional disorders of liver with fatal outcome during valproic acid (2-PPA)
therapy in siblings.
C.Hepatic porphyria
D.Present liver disease (bilirubin should be below UNL 22µmol/L, ALT below UNL of
60 IU/L, or AST below UNL of 45 U/L)
E.Presence of pancreatic dysfunction (p-alpha-amylase below UNL 300 IU/L)
F.Decreased renal function (serum creatinine below UNL of 133 µmol/L in men, 115
µmol/L in women)
G.Haematologic disorder like bleeding disorder or coagulation abnormalities (partial
thromboplastin time (PTT) > 1.5 x UNL), bone marrow disorders
H.Porphyria, metabolic diseases (especially congenital enzymopathy), systemic
lupus erythematosus or hypoproteinaemia
I.Hypertension (BP above 140/90)
7. Other skin conditions that might interfere with acne diagnosis and/or evaluation
(such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and
papulo-pustular rosacea)
8. History of hypersensitivity to any of the substances in the test drug or in the placebo
9. Treatment with any systemic acne drug within the last 3 months prior to the day 1
assessment and within 6 months for systemic retinoids
10. Treatment with any other topical acne drug within the last 14 days prior to the day
1 assessment
11. Presence of a significant uncontrolled cardiovascular, neurologic, malignant,
psychiatric, respiratory or hypertensive disease
12. Recent history of alcohol or any other substance abuse
13. Treatment with any experimental drug within 30 days prior to the day 1
assessment
14. Inability to comply with the study protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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