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

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ClinicalTrials.gov Identifier: NCT01347879
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Photocure

Tracking Information
First Submitted Date  ICMJE May 3, 2011
First Posted Date  ICMJE May 4, 2011
Results First Submitted Date  ICMJE September 23, 2013
Results First Posted Date  ICMJE January 16, 2014
Last Update Posted Date January 16, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules). [ Time Frame: From baseline to 12 weeks after first treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
Absolute change from baseline in facial inflammatory lesion count (nodules, papules, and pustules) 12 weeks after the first treatment.
Change History Complete list of historical versions of study NCT01347879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [ Time Frame: From baseline to 12 weeks after the first treatment ]
  • Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts. [ Time Frame: From baseline to 12 weeks after the first treatment ]
  • Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment. [ Time Frame: From baseline to 12 weeks after first treatment ]
    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.
  • Pain During Illumination. [ Time Frame: Immediately after first treatment ]
    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.
  • Number of Patients With Adverse Events. [ Time Frame: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration ]
  • Erythema Score of Mild and Moderate [ Time Frame: Immediately after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Clear and Almost Clear Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
  • Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [ Time Frame: From baseline to 12 weeks after first treatment ]
  • Erythema Score of Severe [ Time Frame: Immediately after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Erythema Score of Mild and Moderate [ Time Frame: 2 days after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Erythema Score of Severe [ Time Frame: 2 days after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Mild and Moderate Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
  • Severe and Very Severe Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
Official Title  ICMJE PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Visonac PDT
    cream application prior to illumination with red light
    Other Name: red light
  • Drug: Vehicle cream with PDT
    placebo/vehicle cream application prior to illumination with red light
    Other Name: red light
Study Arms  ICMJE
  • Experimental: Visonac cream with PDT
    active treatment with light dose of 37 Joule/cm2
    Intervention: Drug: Visonac PDT
  • Placebo Comparator: Vehicle cream with PDT
    Placebo treatment, Light dose 37 Joule/cm2
    Intervention: Drug: Vehicle cream with PDT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
153
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2011)
150
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01347879
Other Study ID Numbers  ICMJE PCTA206/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Photocure
Study Sponsor  ICMJE Photocure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Pariser, MD Virginia Clinical Research, Inc.
PRS Account Photocure
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP