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Acne VulgarisPhase 2NCT05080764

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults

A Phase 2 study testing 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) and 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) in people with Acne Vulgaris, run by Biofrontera Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Acne Vulgaris
What is being tested?
1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) and 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
9 sitesUnited States
Study dates
10 Dec 2021to 7 Jan 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Willingness and ability of the subject to provide informed consent and to sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures. Minors under 18 years of age must be accompanied by the parent(s) or legal guardian(s) at the time of consent signing. The parent(s) or legal guardian(s) must also provide informed consent/HIPAA for the subject.
  • Subjects with moderate to severe acne on the face (IGA ≥3).
  • Presence of ≥20 inflammatory and ≥20 non-inflammatory (open and closed comedones) Acne vulgaris lesions on the face (should be located within not more than 2 illumination areas) as assessed by investigator.
  • All sexes, ≥16 years of age.
  • Willingness and ability to comply with study procedures, particularly willingness to receive up to 3 PDTs within 8 to 10 weeks.
  • Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study.
  • Willingness to stop topical facial treatments other than medical cleansers (i.e. face washes etc.) at least 14 days prior to randomization visit (Visit 2, baseline) and discontinue medical cleansers in the face at least 1 week prior to randomization visit (Visit 2, baseline) and thereafter until the end of study (use of soap is allowed but the product used should not be changed during the study).
  • Females of reproductive potential must have a negative serum pregnancy test and must use an adequate and highly effective or two effective methods of contraception throughout the study. (If hormonal contraception is used, the same product and dose should be taken for at least 6 months before the first treatment and throughout the entire study.)

Who cannot join

  • Any known history of hypersensitivity to ALA, porphyrins or excipients of BF-200 ALA.
  • History of soy or peanut allergy.
  • Subjects with sunburn or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) within or in close proximity (< 5 cm distance) to treatment field. (Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within the screening period.
  • Reassessment can be done on the day of the actual treatment.)
  • Clinical diagnosis of atopic dermatitis and other cutaneous conditions (e.g. lupus erythematosus), Bowen's disease, BCC, eczema, psoriasis, acne conglobate, acne fulminans, or secondary acne (steroid-induced acne, perioral dermatitis, acne rosacea), squamous cell carcinoma, other malignant or benign tumors in the treatment field.
  • Clinically significant (CS) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
Show all 39Show fewer
  • Presence of photodermatoses or porphyria
  • Metastatic tumor or tumor with high probability of metastasis
  • Infiltrating skin neoplasia (suspected or known)
  • Unstable cardiovascular disease (New York Heart Association class III, IV)
  • Unstable hematologic (including Myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
  • Unstable collagen-vascular condition
  • Unstable gastrointestinal condition
  • Immunosuppressive condition
  • Presence of clinically significant inherited or acquired coagulation defect
  • Beard or other facial hair that might interfere with the study assessments unless subject agrees to be clean-shaven throughout the entire study period. (Reassessment of subjects is allowed once if assessment of acne lesions is impaired by facial hair at screening. Reassessment can be performed on the day of the actual treatment).
  • Facial procedures such as dermabrasion, chemical or laser peels as well as exposure to UV radiation (other than sunlight) at least 4 weeks prior to randomization visit (Visit 2, baseline).
  • Presence of strong artificial pigmentation (e.g. tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.
  • Suspicion of drug or alcohol abuse.
  • Any topical medication of the skin prior to screening as defined below:
  • Topical treatment with ALA or ALA-esters (e.g. MAL) or an investigational drug in- and outside the treatment field within 8 weeks prior to screening.
  • Topical treatment with immunosuppressive, cytostatic or cytotoxic drugs inside the treatment field within 8 weeks prior to screening.
  • Start of a regular and continuous topical administration of medication with hypericin or other drugs with phototoxic or photoallergic potential inside the treatment field within 4 weeks prior to screening. Subjects may, however, be eligible if such medication was regularly applied for more than 4 weeks prior to screening visit without evidence of an actual phototoxic/photoallergic reaction or if such medication is only administered for a limited time (e.g. an antibiotic)
  • Any use of the below specified systemic treatments within the designated periods:
  • Systemic acne therapy (oral antibiotics within 8 weeks or oral isotretinoin within 6 months or start with hormonal therapy for acne within 6 months prior to Visit 2).
  • Use of cytotoxic or cytostatic drugs within 6 months, or immunosuppressive therapies or use of ALA or ALA-esters (e.g. MAL) within 12 weeks, investigational drugs or drugs known to have major organ toxicity within 8 weeks, interferon or glycocorticosteroids (oral or injectable) within 6 weeks prior to screening.
  • Start of long-term intake of medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be screened and randomized if such medication was taken in or was regularly applied for more than 8 weeks prior to screening visit without evidence of an actual phototoxic/photoallergic reaction or if such a drug is only used for a limited time (e.g. an antibiotic).
  • Breast feeding women.
  • Subject unlikely to comply with protocol, e.g. inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator.
  • Prior randomization in the study.
  • A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof.
  • Simultaneous participation in a further clinical study.
  • Four or more nodular acne lesions on the face.
  • Unwillingness or inability to limit sun exposure for 48 hours post PDT treatment.
  • Dosing Day exclusion criteria:
  • Febrile or infectious disease within 7 days prior to PDT visits.
  • Subjects with sunburn, wounds, irritations, bleeding or other confounding skin conditions within illumination areas at PDT visits.
  • Application of topical glycocorticosteroids in- and outside the treatment field within 7 days prior to PDT visits
  • Administration of (topical or systemic) medication with phototoxic/photoallergic potential for a limited time. After discontinuing the medication, a wash out period of the medications 5-fold half-life time should be applied prior to the next PDT.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • DermResearch PA

    Austin, Texas, 78759

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

  • Dermatology Associates PA of the Palm Beaches

    Delray Beach, Florida, 33445

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Austin Institute for Clinical Research Inc.

    Pflugerville, Texas, 78660

  • Skin Search of Rochester, Inc

    Rochester, New York, 14623

  • Cosmetic Laser Dermatology

    San Diego, California, 92121

  • ForCare Clinical Research

    Tampa, Florida, 17033

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Vehicle-controlled, Multicenter Phase II Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris in Adults With Photodynamic Therapy (PDT)

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.

Conditions
Acne Vulgaris
Being tested
1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient), 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), 3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
Keywords
ALA-PDT
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)Combination product

    The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 1 hour. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).

    Other Names:

    ALA-PDT, Ameluz®-PDT

  • 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)Combination product

    The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 1h. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).

  • 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)Combination product

    The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 3 hours. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).

    Other Names:

    ALA-PDT, Ameluz®-PDT

  • 3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)Combination product

    The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 3h. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).

Study groups in NCT05080764
Study groupRoleWhat they receive
1h incubation BF-200 ALAExperimentalTopical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.
Receives: Combination Product: 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
3h incubation BF-200 ALAExperimentalTopical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation.
Receives: Combination Product: 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
1h incubation vehiclePlacebo comparatorTopical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.
Receives: Combination Product: 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
3h incubation vehiclePlacebo comparatorTopical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation.
Receives: Combination Product: 3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Change in the Number of Inflammatory Lesions (Relative Change From Baseline) 8 Weeks After the Last PDT as Assessed by Investigator.

    Outcome 1 is the relative change in the number of inflammatory lesions at the final visit with respect to baseline as assessed by the investigator.

    Measured: 8 weeks after the last PDT

  2. Treatment Success Defined by a Minimum Improvement of the Modified Investigator Global Assessment (mIGA) Score by at Least 2 Assessed 8 Weeks After the Last PDT and Resulting in an mIGA Score of 0 (Clear) or 1 (Almost Clear).

    Treatment success is defined as a minimum improvement of the mIGA score by at least 2 and resulting in an mIGA score of 0 (clear) or 1 (almost clear).

    Measured: 8 weeks after the last PDT

Secondary outcomes (17)

  1. Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator (After the Last PDT).

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after the last PDT
    2. Inflammatory lesions - 8 weeks after the last PDT
    3. Non-inflammatory lesions - 4 weeks after the last PDT
    4. Non-inflammatory lesions - 8 weeks after the last PDT
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after the last PDT
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after the last PDT

    Measured: 4 or 8 weeks after the last PDT

  2. Percentage Change From Baseline in the Number of Lesions as Assessed by Investigator (After the Last PDT).

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after the last PDT
    2. Inflammatory lesions - 8 weeks after the last PDT
    3. Non-inflammatory lesions - 4 weeks after the last PDT
    4. Non-inflammatory lesions - 8 weeks after the last PDT
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after the last PDT
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after the last PDT

    Measured: 4 or 8 weeks after the last PDT

  3. Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator (After Each PDT).

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-1
    2. Non-inflammatory lesions - 4 weeks after PDT-1
    3. Inflammatory and non-inflammatory lesions - 4 weeks after PDT-1
    4. Inflammatory lesions - 4 weeks after PDT-2
    5. Non-inflammatory lesions - 4 weeks after PDT-2
    6. Inflammatory and non-inflammatory lesions - 4 weeks after PDT-2
    7. Inflammatory lesions - 4 weeks after PDT-3
    8. Non-inflammatory lesions - 4 weeks after PDT-3
    9. Inflammatory and non-inflammatory lesions - 4 weeks after PDT-3
    10. Inflammatory lesions - 8 weeks after PDT-3
    11. Non-inflammatory lesions - 8 weeks after PDT-3
    12. Inflammatory and non-inflammatory lesions - 8 weeks after PDT-3

    Measured: 4 or 8 weeks after the last PDT

  4. Percentage Change From Baseline in the Number of Lesions as Assessed by Investigator (After Each PDT).

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-1
    2. Non-inflammatory lesions - 4 weeks after PDT-1
    3. Inflammatory and non-inflammatory lesions - 4 weeks after PDT-1
    4. Inflammatory lesions - 4 weeks after PDT-2
    5. Non-inflammatory lesions - 4 weeks after PDT-2
    6. Inflammatory and non-inflammatory lesions - 4 weeks after PDT-2
    7. Inflammatory lesions - 4 weeks after PDT-3
    8. Non-inflammatory lesions - 4 weeks after PDT-3
    9. Inflammatory and non-inflammatory lesions - 4 weeks after PDT-3
    10. Inflammatory lesions - 8 weeks after PDT-3
    11. Non-inflammatory lesions - 8 weeks after PDT-3
    12. Inflammatory and non-inflammatory lesions - 8 weeks after PDT-3

    Measured: 4 or 8 weeks after the last PDT

  5. Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 3 / 4 Weeks After PDT-1.

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-1
    2. Inflammatory lesions - 8 weeks after PDT-1
    3. Non-Inflammatory lesions - 4 weeks after PDT-1
    4. Non-Inflammatory lesions - 8 weeks after PDT-1
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after PDT-1
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after PDT-1

    Measured: 4 or 8 weeks after PDT-1

  6. Percentage Change From Baseline in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 3 / 4 Weeks After PDT-1.

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-1
    2. Inflammatory lesions - 8 weeks after PDT-1
    3. Non-Inflammatory lesions - 4 weeks after PDT-1
    4. Non-Inflammatory lesions - 8 weeks after PDT-1
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after PDT-1
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after PDT-1

    Measured: 4 or 8 weeks after PDT-1

  7. Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 4b / 4 Weeks After PDT-2.

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-2
    2. Inflammatory lesions - 8 weeks after PDT-2
    3. Non-Inflammatory lesions - 4 weeks after PDT-2
    4. Non-Inflammatory lesions - 8 weeks after PDT-2
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after PDT-2
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after PDT-2

    Measured: 4 or 8 weeks after PDT-2

  8. Percentage Change From Baseline in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 4b / 4 Weeks After PDT-2.

    In particular, the following will be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-2
    2. Inflammatory lesions - 8 weeks after PDT-2
    3. Non-Inflammatory lesions - 4 weeks after PDT-2
    4. Non-Inflammatory lesions - 8 weeks after PDT-2
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after PDT-2
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after PDT-2

    Measured: 4 or 8 weeks after PDT-2

  9. Absolute Change in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 5b / 4 Weeks After PDT-3.

    In particular, the following be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-3
    2. Inflammatory lesions - 8 weeks after PDT-3
    3. Non-Inflammatory lesions - 4 weeks after PDT-3
    4. Non-Inflammatory lesions - 8 weeks after PDT-3
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after PDT-3
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after PDT-3

    Measured: 4 or 8 weeks after PDT-3

  10. Percentage Change in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 5b / 4 Weeks After PDT-3.

    In particular, the following be assessed:

    1. Inflammatory lesions - 4 weeks after PDT-3
    2. Inflammatory lesions - 8 weeks after PDT-3
    3. Non-Inflammatory lesions - 4 weeks after PDT-3
    4. Non-Inflammatory lesions - 8 weeks after PDT-3
    5. Inflammatory \& non-inflammatory lesions - 4 weeks after PDT-3
    6. Inflammatory \& non-inflammatory lesions - 8 weeks after PDT-3

    Measured: 4 or 8 weeks after PDT-3

  11. Absolute Change in the Number of Nodules & Cysts

    The number of nodules and cysts was assessed by investigator.

    Measured: 8 weeks after the last PDT

  12. Percentage Change in the Number of Nodules & Cysts

    The number of nodules and cysts was assessed by investigator. Percentage change from baseline was calculated only for participants whose number of nodules and cysts had changed at 8 weeks after the last PDT.

    Measured: 8 weeks after the last PDT

  13. Treatment Success Defined by a Minimum Improvement of the IGA by at Least 2.

    Treatment success is defined as a minimum improvement of the IGA score by at least 2 (from baseline (Visit 2) as assessed by investigator).

    Measured: 8 weeks after the last PDT

  14. Improvement of the IGA.

    As assessed by the investigator.

    Measured: 8 weeks after the last PDT

  15. Improvement of the mIGA.

    As assessed by the investigator.

    Measured: 8 weeks after the last PDT

  16. Improvement of Scar Severity and Overall Esthetic Appearance.

    Improvement of scar severity: As assessed by the investigator via a physical global scale for acne scars (PGA).

    Overall esthetic appearance: As assessed by the investigator using a 4-point scale (0= very good, 1 = good, 2 = satisfactory, 3 = unsatisfactory)

    Measured: 8 weeks after last PDT

  17. Satisfaction Regarding Esthetic Outcome and Treatment.

    As reported by the subject. Subject's Satisfaction with PDT (No = No, I would not choose this treatment again; Yes = Yes, I would choose this treatment again) Assessment of Esthetic Outcome (0=Very good, 1=Good, 2=Satisfactory, 3=Unsatisfactory)

    Measured: 8 weeks after the last PDT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start10 Dec 2021
  3. Primary completion22 Aug 2025
  4. Study completion7 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080764
Sponsor's protocol ID
ALA-ACV-CT014
Status last verified
Sep 2026
First submitted
9 Sep 2021
Last updated
1 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) and 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) in people with Acne Vulgaris, run by Biofrontera Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change in the Number of Inflammatory Lesions (Relative Change From Baseline) 8 Weeks After the Last PDT as Assessed by Investigator. (time frame: 8 weeks after the last PDT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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