A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Acne Vulgaris - Safety and Efficacy Study of DGLA Cream in Patients with Acne Vulgaris

Dignity Sciences Limited0 sites150 target enrollmentApril 18, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with mild to moderate facial papulopustular acne (acne comedonica or acne papulopustulosa) will be enrolled in the study.
Sponsor: Dignity Sciences Limited
Enrollment: 150
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

April 18, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Dignity Sciences Limited

•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 Grading) and with at least 12 inflammatory lesions excluding the nose
•2\. General good health as confirmed by a physical examination and by medical history
•3\. Acceptance to abstain from any other systemic or topical acne treatment during trial
•4\. Acceptance to abstain from prolonged UV exposure via intensive sunbathing, the use of tanning equipment or outdoor pursuits such as mountain sports activities
•5\. Male or female patients aged 16 to 40 years on the day of signing the informed consent form (ICF).
•6\. Patients who are able and willing to give signed informed consent (ICF).
•7\. Body mass index (BMI) of between 18 and 30 kg/m2 inclusive.
•8\. Patients taking oral contraceptives containing compounds with known effects on acne are allowed providing that the subject has been on stable dose for 6 months prior to enrollment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24

•1\. Females with a positive pregnancy test at baseline
•2\. Females of childbearing potential and female partners of male patients who have not used for 6 months prior to the trial and are not willing to use for the duration of the trial; a safe contraceptive measure (e.g. IUD or oral contraceptives, diaphragm or condom if used in combination with a spermicide)
•3\. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne, cosmetic induced acne
•4\. Presence of more than 2 nodules on the face. Up to two nodules are allowed.
•5\. Localisation of acne that requires treatment predominantly on the chest and/or the back
•6\. Patients with any clinically significant abnormal laboratory results at screening (biochemistry, haematology, urinalysis).
•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\. Treatment with any of the following medications within a timeframe prior to screening assessment of:
•\-Corticosteroids, antibiotics (except plain penicillins) 4 weeks
•\-Other systemic acne treatments (including isotretinoin) 6 months