Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

Acne Vulgaris Clinical Trial

Official title:

A Double Blinded, Prospective, Randomized, Stratified, Placebo-controlled, Multi-center Study of Photodynamic Therapy With VisonacTM Cream in Patients With Moderate to Severe Acne Vulgaris.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933543
• Other study ID #: PC TA204/09
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2009
• Last updated: November 15, 2013
• Start date: August 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2013
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)

Description:

Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment.

Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment.

Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 35 Years

Eligibility

Inclusion Criteria:

• Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4).

• Female patients who are surgically sterile, pre-menstrual, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to T1. Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months.

• Fitzpatrick skin type I through VI.

• Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face.

• Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face.

• Patients with no more than 2 nodular lesions on the face.

• Signed and verified informed consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

• Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

• Patients unlikely to comply with the protocol, e.g., mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g., drug or alcohol abuse).

• Female patients using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study.

• Pregnancy

• Patients undergoing testosterone or any other systemic hormonal treatment.

• Patients using hormonal contraceptives solely for the control of acne.

• Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.

• Patients with porphyria.

• Patients with cutaneous photosensitivity.

• Participation in other clinical studies either concurrently or within the last 30 days, before T1.

• Patients with a washout period for topical treatments e.g., topical BPOs, retinoids and antibiotics, for their acne of less than 14 days, before T1. Medicated cleansers may be used during the washout period and stopped before the treatment.

• Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month, before T1.

• Patients with a washout period for oral isotretinoin of less than 6 months, before T1.

• Patients with a beard or other facial hair that might interfere with study assessments.

• Patients with melanoma or dysplastic nevi in the treatment area.

• Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.

• Exposure to PDT within 12 weeks before T1.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Visonac PDT (MAL PDT)
Cream application followed by illumination with red light.
• Vehicle cream (placebo)
Cream application followed by illumination with red light.

Procedure:
• PDT
Photodynamic Therapy - Light dose 37 J/cm2

Locations

Country	Name	City	State
Canada	INNOVADERM Research Inc.	Montreal	Quebec
Canada	Centre de Recherche Dermatologique	Québec	Quebec
Canada	Windsor Clinical Research, Inc.	Windsor, Ontario N8W 5L7	Ontario
United States	DeNova Research	Chicago	Illinois
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Madison Skin & Research, Inc	Madison	Wisconsin
United States	Dermatology Institute of DuPage Medical Group	Naperville	Illinois
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Children's Specialists of San Diego / Rady Children's Hospital San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.		12 weeks after the first treatment	No
Primary	Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)		12 weeks after the first treatment	No
Primary	Absolute Change From Baseline in Facial Non Inflammatory Lesion Count		12 weeks after first treatment	No
Secondary	Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count		6 weeks after the first treatment	No
Secondary	Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count		12 weeks after the first treatment	No
Secondary	Percent Change From Baseline in Facial Non Inflammatory Lesion Count		6 weeks after first treatment	No
Secondary	Percent Change From Baseline in Facial Non Inflammatory Lesion Count		12 weeks after first treatment	No
Secondary	Percent Change From Baseline in Facial Total Lesion Count		6 weeks after the first treatment	No
Secondary	Percent Change From Baseline in Facial Total Lesion Count		12 weeks after the first treatment	No
Secondary	Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count		12 weeks after last treatment	No
Secondary	Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline		12 weeks after first treatment	No
Secondary	Absolute Change From Baseline in Facial Inflammatory Lesion Count		6 weeks after the first treatment	No
Secondary	Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count		6 weeks after the first treatment	No
Secondary	Absolute Change From Baseline in Facial Total Lesion Count		6 weeks after the first treatment	No
Secondary	Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.		6 weeks after the first treatment	No
Secondary	Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after first treatment	Yes
Secondary	Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after second treatment	Yes
Secondary	Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after third treatment	Yes
Secondary	Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after fourth treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hyperpigmentation		at 12 weeks after first treatment	Yes
Secondary	Proportion of Patients With Severe Hyperpigmentation		at 12 weeks after first treatment	Yes
Secondary	Proportion of Patients With Mild or Moderate Scarring at End of Study		week 12	Yes
Secondary	Proportion of Patients With Clear or Almost Clear Scarring at End of Study		week 12	Yes
Secondary	Proportion of Patients With Severe and Very Severe Scarring at End of Study		week 12	Yes
Secondary	Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)		at 12 weeks after first treatment	Yes
Secondary	Proportion of Patients With Dryness (Mild)		at 12 weeks after first treatment	Yes