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

• Conditions: Acne vulgaris of mild to moderate intensity; MedDRA version: 9.1Level: LLTClassification code 10000519Term: Acne vulgaris

• Registration Number: EUCTR2007-000418-35-DE
• Lead Sponsor: TopoTarget A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-09
• Last Update Posted: 19 March 2012

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. Female Subjects of childbearing potential with a negative pregnancy test at the
screening visit and must practice a highly effective method of contraception (implant,
injectable, combined oral contraceptive, IUD, strict sexual abstinence or
vasectomised partner) during the study (including the 4 weeks after end of
treatment) combined with a barrier method (e.g. diaphragm or condom)
5. Acceptance of oil-free skin care products
6. Acceptance to abstain from any other systemic or topical acne treatment during trial
7. Acceptance to abstain from sun bathing and the solarium
8. 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. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne,
cosmetic induced acne
2. Localisation of acne that requires treatment predominantly on the chest and/or the
back
3. Patients with a personal or family history of cutaneous epithelioma
4. Nursing women
5. 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)
6. Other skin conditions that might interfere with acne diagnosis and/or evaluation
(such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and
papulo-pustular rosacea)
7. History of hypersensitivity to valproic acid (2-PPA) or any other ingredient in the test
drug or in the placebo
8. Treatment with any systemic acne drug within the last 3 months prior to the day 1
assessment and within 6 months for systemic retinoids
9. Treatment with any other topical acne drug within the last 14 days prior to the day
1 assessment
10. Presence of a significant uncontrolled cardiovascular, neurologic, malignant,
psychiatric, respiratory or hypertensive disease
11. Recent history of alcohol or any other substance abuse
12. Treatment with any experimental drug within 30 days prior to the day 1
assessment
13. 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
Main Objective: The primary objective of the study is to compare the efficacy of different concentrations of the study treatment Avugane™ on facial papulopustular acne in comparison to a placebo control.;Secondary Objective: The secondary objectives are to assess the safety, tolerability and the bioavailability of topically applied Avugane™ in different concentrations.;Primary end point(s): The primary endpoint to evaluate efficacy of Avugane™ in relation to the concentration used in the treatment of acne vulgaris is the mean change from baseline to the end of week 12 of treatment for the total count of acne lesions.