Open-label, within-subject controlled, Phase IIa study to investigate repeat dose antimicrobial photodynamic therapy in patients with acne vulgaris. - Acne treatment by photodynamic therapy. Version 1

• Conditions: Acne vulgaris; MedDRA version: 12.1Level: LLTClassification code 10000519Term: Acne Vulgaris

• Registration Number: EUCTR2010-018313-29-GB
• Lead Sponsor: Photopharmica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or female subjects of any race, aged 16 to 35 years inclusive, with truncal acne vulgaris.

Subjects will have voluntarily read, signed and dated the approved Informed Consent Form (ICF) prior to any participation in the study.

Have a minimum of 15 inflammatory lesions (papules and pustules) within each of the allocated treatment areas of 72 sq cm on the back.

Have a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) within each of the allocated treatment areas of 72 sq cm on the back.

Subjects will have a Propionibacterium acnes microbiology scrub taken of each pre-identified treatment area to confirm that the total bacterial load of each area is equal to or greater than 10,000 CFU/sq cm, determined within 2 weeks of the first dose.

Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at the screening visit prior to first dose if no menstrual cycle within previous 4 weeks and must practice a highly effective method of contraception during the study: oral contraception (must have been on a stable dose for 3 months prior to study entry and for duration of study), IUD, systemic (injectable or patch) contraception, strict abstinence or partner had a vasectomy.
Are the trial subjects under 18? yes
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

Subjects under 16 years of age.

Subjects with acne cystic lesions.

Female subjects who are pregnant, nursing or planning a pregnancy during the study.

Subjects with known allergy to one of the components of the gel formulation (methyl cellulose and propylene glycol).

Subjects who have participated in another investigational drug or device research study within 30 days of enrollment/ baseline.

Subjects currently on photosensitising medication or a history of photosensitivity disorders or cutaneous photosensitisation.

Subjects who are known to abuse alcohol or drugs currently, or have psychological disorders that could affect follow up care or treatment outcomes.

Subjects who have any skin pathology or condition (e.g. eczema) that would interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.

Subjects who have used OTC (over the counter) acne medicated cleansers or soaps within two weeks of initiation of treatment to the treatment area.

Subjects with more than 2 nodules in the treatment area (nodule= lesion greater than or equal to 0.5cm in diameter).

Subjects who plan to be exposed to artificial tanning devices, ultraviolet light or excessive sunlight during the trial.

Subjects with a wash-out period for topical treatment on the back less than
•2 weeks- Corticosteroids, antibiotics, antiseptics, benzoyl peroxide, salicylic acid, other anti-inflammatory drugs, or other acne treatments
•4 weeks- Retinoids, including tazarotene, adapalene, tretinoin
•8 weeks- Light treatments, microdermabrasion or chemical peels
•2 weeks- Zinc containing drugs

Subjects who have used any of the following systemic anti-acne medications:

4 weeks- Corticosteroids (including intramuscular and intralesional injections) Inhaled corticosteroids allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation treatment)
4 weeks- Antibiotics
4 weeks- Nicotinamide
4 weeks- Spironolactone
6 months-Retinoid Therapy

Subjects with back hair that in the opinion of the investigator could interfere with the study assessments.

Subjects with acne conglobata, acne fulmicans, secondary acne (chloracne, drug induced etc) or severe nodulocystic acne requiring treatment with oral isotretinoin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if repeat treatments with a new drug and light combination (photodynamic therapy) can cause a reduction in lesion (spot) counts in subjects with acne vulgaris on the upper back.;Secondary Objective: To determine if repeat treatments with a new drug and light combination(photodynamic therapy) can cause a reduction in the bacteria count (Propionibacterium acnes) of acne vulgaris on the upper back. <br><br>To determine if repeat treatments with a new drug and light combination(photodynamic therapy)can alter the severity of acne vulgaris. <br><br>To monitor the safety of repeat treatments with a new drug and light combination (photodynamic therapy).<br><br><br>;Primary end point(s): Change in total lesion count (sum of non inflammatory and inflammatory lesions) from baseline to 12 weeks post first dose.