A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347879
• Other study ID #: PCTA206/11
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2011
• Last updated: December 2, 2013
• Start date: May 2011
• Est. completion date: May 2012

Study information

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

Clinical Trial Summary

This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria:

• Female and male patients, from 12-35 years of age with severe facial acne vulgaris (IGA score 4 on IGA scale)

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

• 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 3 months and must agree to stay with the same product and dose for an additional 3 months.

• Fitzpatrick skin type I through VI,

• Patients with 25 to 75 inflammatory lesions (papules, pustules, and nodules) on the face.

• Patients with 20 to 100 non-inflammatory lesions (open and closed comedones) on the face.

Exclusion Criteria:

• Patients with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

• Patients with more than 3 nodules on the face.

• 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 study.

• 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 with childbearing potential (i.e. ovulation, pre-menopausal, not surgically sterilized) and sexually active, not willing to use a medically accepted contraceptive regimen (as described under inclusion criteria) while on treatment.

• Pregnancy.

• Nursing.

• Participation in other clinical studies either currently or within the last 30 days.

• Patients with porphyria.

• Patients with cutaneous photosensitivity.

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

• Patients using testosterone, any other systemic hormonal treatment or hormonal contraceptives solely for control of acne.

• Patients who have received topical treatments for their facial acne within the last 14 days (e.g steroids, retinoids, glycolic acid, benzoyl peroxide, anti inflammatory agents, antibiotics). Medicated cleansers may be used during the washout period and stopped before the treatment.

• Patients who have received oral antibiotics for treatment of their acne within the last month.

• Patients who have received oral isotretinoin within the last 6 months.

• Patient who have received facial procedures like dermabrasion, chemical or laser peels within the last 1 month.

• Patients using testosterone, any systemic hormonal treatment for other reasons than acne treatment and has not been on the same product and dose for at least 3 months

• Patients with moderate, severe or very severe facial acne scarring according to scarring scale described in section 10.4.3.

• Patients with a beard 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
cream application prior to illumination with red light
• Vehicle cream with PDT
placebo/vehicle cream application prior to illumination with red light

Locations

Country	Name	City	State
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	DermResearch Inc	Austin	Texas
United States	Deaconess Clinic Inc	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	ActivMed Practices & Research Inc	Haverhill	Massachusetts
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	North Florida Dermatology Associates	Jacksonville	Florida
United States	Clinical Partners LLC	Johnston	Rhode Island
United States	Dermatology Institute, DuPage Medical Group	Naperville	Illinois
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Dermatology Specialists Inc	Oceanside	California
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Rady Children's Hospital	San Diego	California
United States	Premier Clinical Research	Spokane	Washington
United States	Somerset Skin Centre	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).		From baseline to 12 weeks after first treatment	No
Secondary	Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)		From baseline to 12 weeks after the first treatment	No
Secondary	Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.		From baseline to 12 weeks after the first treatment	No
Secondary	Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.	One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.	From baseline to 12 weeks after first treatment	No
Secondary	Pain During Illumination.	Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.	Immediately after first treatment	Yes
Secondary	Number of Patients With Adverse Events.		From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration	Yes
Secondary	Erythema Score of Mild and Moderate	Clinical assessment using a 4 point scale; none, mild, moderate, severe	Immediately after first treatment	Yes
Secondary	Clear and Almost Clear Scarring According to Scarring Score	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe	at week 12 after first treatment	No
Secondary	Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)		From baseline to 12 weeks after first treatment	No
Secondary	Erythema Score of Severe	Clinical assessment using a 4 point scale; none, mild, moderate, severe	Immediately after first treatment	Yes
Secondary	Erythema Score of Mild and Moderate	Clinical assessment using a 4 point scale; none, mild, moderate, severe	2 days after first treatment	Yes
Secondary	Erythema Score of Severe	Clinical assessment using a 4 point scale; none, mild, moderate, severe	2 days after first treatment	Yes
Secondary	Mild and Moderate Scarring According to Scarring Score	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe	at week 12 after first treatment	No
Secondary	Severe and Very Severe Scarring According to Scarring Score	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe	at week 12 after first treatment	No