Trials Sponsors Conditions Drugs Pricing

Conditions

Acne Vulgaris

Keywords

Acne VulgarisModerate to severe

Outcome Measures

Primary Outcomes (3)

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
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
12 weeks after the first treatment
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
12 weeks after first treatment

Secondary Outcomes (23)

Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
6 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
12 weeks after the first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
6 weeks after first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
12 weeks after first treatment
Percent Change From Baseline in Facial Total Lesion Count
6 weeks after the first treatment
+18 more secondary outcomes

Study Arms (2)

Visonac cream with PDT

EXPERIMENTAL

Active treatment, Light dose 37 J/cm2.

Drug: Visonac PDT (MAL PDT)Procedure: PDT

Vehicle cream with PDT

PLACEBO COMPARATOR

Placebo treatment, Light dose 37 J/cm2.

Drug: Vehicle cream (placebo)Procedure: PDT

Interventions

Visonac PDT (MAL PDT)Drug

Cream application followed by illumination with red light.

Also known as: Visonac, MAL PDT, red light

Visonac cream with PDT

Vehicle cream (placebo)Drug

Cream application followed by illumination with red light.

Also known as:

Eligibility Criteria

Age9 Years - 35 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Photocure
Industrylead

Study Sites (11)

Children's Specialists of San Diego / Rady Children's Hospital San Diego

San Diego, California, 92123, United States

DeNova Research

Chicago, Illinois, 60611, United States

Dermatology Institute of DuPage Medical Group

Naperville, Illinois, 60563, United States

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Virginia Clinical Research, Inc.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Red Light1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical Phenomena

Results Point of Contact

Title: Project director Per Fuglerud
Organization: Photocure

Study Officials

Lawrence F. Eichenfield, M.D
Children's Specialists of San Diego / Rady Children's Hospital San Diego
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

107 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

August 2009

Date type not reported

This date has not been verified as actual or estimated.

Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (23)

Study Arms (2)

Visonac cream with PDT

Vehicle cream with PDT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (23)

Study Arms (2)

Visonac cream with PDT

Vehicle cream with PDT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations