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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01689935
First received: October 5, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: 20 % Aminolevulinic Acid
Device: Red light only
Device: Blue light only
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial To Reduce Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris [ Time Frame: 0, 4, 8, 12, 16, 24 and 36 weeks ] [ Designated as safety issue: No ]

    0. Clear: No lesions but erythema and residual hyperpigmentation may be present

    1. Almost Clear: few scattered comedones and a few (< five) small papules
    2. Mild:< 50% face involved, many comedones/papules and pustules
    3. Moderate:> 50% of face involved. Numerous comedones, papules and pustules
    4. 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 [ Time Frame: During, immediately after and 24 h after treatment ] [ Designated as safety issue: Yes ]
    Visual Pain Scale - 0 (no pain) -10 (severe pain)


Other Outcome Measures:
  • Side-effects Profile [ Time Frame: Immediately after treatment and during follow-up visits ] [ Designated as safety issue: Yes ]
    Evaluation of overall side-effects of each test site


Estimated Enrollment: 35
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No drug, no treatment
Active Comparator: ALA-PDT
Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT
Drug: 20 % Aminolevulinic Acid
topical medication for ALA-PDT and i-PDT
Other Name: 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)
Experimental: i-PDT
Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
Drug: 20 % Aminolevulinic Acid
topical medication for ALA-PDT and i-PDT
Other Name: 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)
Device: Blue light only
Blue light only
Other Names:
  • Omnilux Blue
  • 415 nm LED (Phototherapeutics, Cheshire, UK)
Active Comparator: Red Light only
Red light only - no drug
Device: Red light only
Red Light therapy
Other Names:
  • Omnilux Revive
  • 635 nm - LED (Phototherapeutics, Cheshire, UK)
Active Comparator: Blue light only
Blue light only - no drug
Device: Blue light only
Blue light only
Other Names:
  • Omnilux Blue
  • 415 nm LED (Phototherapeutics, Cheshire, UK)

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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689935

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Richard Rox Anderson, MD Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical Hospital
Study Chair: Fernanda H Sakamoto, MD, PhD Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Rox Anderson, MD, Professor, Harvard Medical School (Dermatology), Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01689935     History of Changes
Other Study ID Numbers: 2009-P-002352
Study First Received: October 5, 2011
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Acne vulgaris
Photodynamic Therapy
Side-effects
Pain

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014