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Reduced Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne (i-PDT) (i-PDT)

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
20 % Aminolevulinic Acid
Red light only
Blue light only
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Photodynamic Therapy, Side-effects, Pain

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  1. Subjects with ages between 14 and 50 years, male or female.
  2. Subjects with severe acne lesions (one or more nodules or cysts present) on their backs or face

  3. Presence of moderate acne on the back and/or face that has been recalcitrant to previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3 months) improvement after using:

    • Accutane® for at least one completed treatment cycle, and/or
    • Oral antibiotic for ≥ 3 months; and/or
    • Topical prescription retinoids (tretinoin - retinoic acid, adapalene, tazarotene or other derivatives) for ≥ 3 months, and/or
    • Topical benzoyl peroxide 2.5% or higher concentrations for ≥ 3 months
    • Hormonal treatments** for ≥ 3 months.
  4. Willingness to participate in the study
  5. Willingness to receive ALA-PDT treatment
  6. Informed consent agreement signed by the subject
  7. Willingness to follow the treatment schedule and post treatment care requirements
  8. Willingness to not use topical or systemic (oral) anti-acne medications including medicated shampoo or soap during the study period.

Exclusion criteria

  1. Subjects receiving concurrent oral retinoids or antibiotics

    ** Subjects with chronic use of antibiotics may be included if proven that its use has not changed the severity of their acne. AND

    *** Chronic use of antibiotic is considered ≥ 2 years of continuous use.

  2. Scarring or infection of the area to be treated
  3. Known photosensitivity
  4. Presence of suntan in the area to be treated
  5. Subjects who have taken medication known to induce photosensitivity in the previous 3 months
  6. Subjects who have had prior oral retinoid (Accutane®) use within 6 months of entering the study
  7. Prior oral antibiotic use within 1 month of entering the study (see exclusion #1)
  8. Topical antibiotic or other topical anti-acne treatments use within 2 weeks of entering the study
  9. Known anticoagulation or thromboembolic condition
  10. Subjects who are immunosuppressed
  11. Subject is unable to comply with treatment, home care or follow-up visits
  12. Subject is pregnant or breast feeding
  13. Subject has a history of being on photosensitive medications (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension]. phenothiazines [used to treat serious emotional problems]).
  14. Known skin sensitivity to blue light
  15. Porphyria (a disorder of the metabolism that can lead to sensitivity to light)
  16. Allergies to chemicals called porphyrins
  17. Subjects who started hormonal treatment (for medical conditions or birth control) within less than 3 months.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Active Comparator

Experimental

Active Comparator

Active Comparator

Arm Label

Control

ALA-PDT

i-PDT

Red Light only

Blue light only

Arm Description

No drug, no treatment

Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT

Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy

Red light only - no drug

Blue light only - no drug

Outcomes

Primary Outcome Measures

Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
0. Clear: No lesions but erythema and residual hyperpigmentation may be present Almost Clear: few scattered comedones and a few (< five) small papules Mild:< 50% face involved, many comedones/papules and pustules Moderate:> 50% of face involved. Numerous comedones, papules and pustules Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts. 1) Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.

Secondary Outcome Measures

Pain reduction
Visual Pain Scale - 0 (no pain) -10 (severe pain)

Full Information

First Posted
October 5, 2011
Last Updated
September 17, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01689935
Brief Title
Reduced Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne (i-PDT)
Acronym
i-PDT
Official Title
A Pilot Clinical Trial To Reduce Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study aims to compare different methods for helping difficult to treat or scarring (cystic) acne, ALA-PDT and i-PDT. There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses a drug called ALA (aminolevulinic acid), which is marketed as Levulan®. Levulan® is applied directly to facial/back acne. This is the way that it is usually applied. Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where the Levulan® was applied is exposed to a red light for activation. The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin through the skin pores to where the glands are. PDT destroys the glands reducing the acne lesion. Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure also has some side effects. Some of the side effects include pain, burning sensation during the procedure, and redness, tenderness, and swelling after the procedure. At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT is aimed at reducing the side-effects of ALA- PDT. The difference between these two procedures is that i-PDT uses a light source that will prevent Levulan® accumulation in the normal skin surface. The investigators would like to find out if Levulan® will be placed only inside the sebaceous glands.
Detailed Description
This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the right and left. One half of the face or back will receive ALA-PDT and the other half will receive i-PDT. For subjects with back acne, red light and blue light alone will be applied for comparison. Healthy subjects with difficult to treat moderate or severe acne on the face or back are eligible to enroll. The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with follow-ups 1, 3 and 6 months after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, Photodynamic Therapy, Side-effects, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No drug, no treatment
Arm Title
ALA-PDT
Arm Type
Active Comparator
Arm Description
Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT
Arm Title
i-PDT
Arm Type
Experimental
Arm Description
Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
Arm Title
Red Light only
Arm Type
Active Comparator
Arm Description
Red light only - no drug
Arm Title
Blue light only
Arm Type
Active Comparator
Arm Description
Blue light only - no drug
Intervention Type
Drug
Intervention Name(s)
20 % Aminolevulinic Acid
Other Intervention Name(s)
5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)
Intervention Description
topical medication for ALA-PDT and i-PDT
Intervention Type
Device
Intervention Name(s)
Red light only
Other Intervention Name(s)
Omnilux Revive, 635 nm - LED (Phototherapeutics, Cheshire, UK)
Intervention Description
Red Light therapy
Intervention Type
Device
Intervention Name(s)
Blue light only
Other Intervention Name(s)
Omnilux Blue, 415 nm LED (Phototherapeutics, Cheshire, UK)
Intervention Description
Blue light only
Primary Outcome Measure Information:
Title
Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
Description
0. Clear: No lesions but erythema and residual hyperpigmentation may be present Almost Clear: few scattered comedones and a few (< five) small papules Mild:< 50% face involved, many comedones/papules and pustules Moderate:> 50% of face involved. Numerous comedones, papules and pustules Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts. 1) Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.
Time Frame
0, 4, 8, 12, 16, 24 and 36 weeks
Secondary Outcome Measure Information:
Title
Pain reduction
Description
Visual Pain Scale - 0 (no pain) -10 (severe pain)
Time Frame
During, immediately after and 24 h after treatment
Other Pre-specified Outcome Measures:
Title
Side-effects Profile
Description
Evaluation of overall side-effects of each test site
Time Frame
Immediately after treatment and during follow-up visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Subjects with ages between 14 and 50 years, male or female. Subjects with severe acne lesions (one or more nodules or cysts present) on their backs or face Presence of moderate acne on the back and/or face that has been recalcitrant to previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3 months) improvement after using: Accutane® for at least one completed treatment cycle, and/or Oral antibiotic for ≥ 3 months; and/or Topical prescription retinoids (tretinoin - retinoic acid, adapalene, tazarotene or other derivatives) for ≥ 3 months, and/or Topical benzoyl peroxide 2.5% or higher concentrations for ≥ 3 months Hormonal treatments** for ≥ 3 months. Willingness to participate in the study Willingness to receive ALA-PDT treatment Informed consent agreement signed by the subject Willingness to follow the treatment schedule and post treatment care requirements Willingness to not use topical or systemic (oral) anti-acne medications including medicated shampoo or soap during the study period. Exclusion criteria Subjects receiving concurrent oral retinoids or antibiotics ** Subjects with chronic use of antibiotics may be included if proven that its use has not changed the severity of their acne. AND *** Chronic use of antibiotic is considered ≥ 2 years of continuous use. Scarring or infection of the area to be treated Known photosensitivity Presence of suntan in the area to be treated Subjects who have taken medication known to induce photosensitivity in the previous 3 months Subjects who have had prior oral retinoid (Accutane®) use within 6 months of entering the study Prior oral antibiotic use within 1 month of entering the study (see exclusion #1) Topical antibiotic or other topical anti-acne treatments use within 2 weeks of entering the study Known anticoagulation or thromboembolic condition Subjects who are immunosuppressed Subject is unable to comply with treatment, home care or follow-up visits Subject is pregnant or breast feeding Subject has a history of being on photosensitive medications (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension]. phenothiazines [used to treat serious emotional problems]). Known skin sensitivity to blue light Porphyria (a disorder of the metabolism that can lead to sensitivity to light) Allergies to chemicals called porphyrins Subjects who started hormonal treatment (for medical conditions or birth control) within less than 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Rox Anderson, MD
Organizational Affiliation
Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernanda H Sakamoto, MD, PhD
Organizational Affiliation
Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Reduced Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne (i-PDT)

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