Non-cutting Laser Therapy in the Treatment of Acne

Photodynamic Therapy in the Treatment of Acne Vulgaris

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113425

Enrollment

Registered

2005-06-08

Start date

2005-08-31

Completion date

2008-11-30

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

non-ablative laser, acne, photosensitizer, photodynamic therapy

Brief summary

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.

Detailed description

Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options. Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available. We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production.

Interventions

DEVICEV-Beam laser, Candela Corp., 595 nm wavelength

Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 15 years or older of either gender and of any racial/ethnic group. * Presence of clinically-evident facial acne. * Subjects must be in generally good health. * Subjects must be able and willing to comply with the requirements of the protocol. * You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion criteria

* Oral retinoid (Accutane) use within 6 months of entry into the study. * Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study. * Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study. * Microdermabrasion or superficial chemical peels at the sites to be treated within 2 months of entry into the study. * Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated. * Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study. * Non-compliant subjects. * Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation. * Subjects using alcohol-based topical solutions or exfoliating agents within 2 weeks of entry into the study. * Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections. * History of keloid (excessive scar) formation for subjects undergoing biopsies. * Pregnant or nursing females. * Subjects with known allergy or hypersensitivity to topical photosensitizing agents. * Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Pustule Acne Lesions at Week 10	Baseline and Week 10	—
Change From Baseline in Cysts at Week 10	Baseline and Week 10	—
Change From Baseline in Papule Acne Lesions at Week 10	Baseline and Week 10	—
Change From Baseline in Closed Comedones at Week 10	Baseline and Week 10	—
Change From Baseline in Open Comedones at Week 10	Baseline and Week 10	—
Change From Baseline in Erythematous Macules at Week 10	Baseline and Week 10	—
Change From Baseline in Acne Severity at Week 10	Baseline and Week 10	The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.

Secondary

Measure	Time frame	Description
Change From Baseline in Erythematous Macules at Week 16	Baseline and Week 16	—
Change From Baseline in Acne Severity at Week 16	Baseline and Week 16	The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Change From Baseline in Papule Acne Lesions at Week 16	Baseline and Week 16	—
Change From Baseline in Pustule Acne Lesions at Week 16	Baseline and Week 16	—
Change From Baseline in Cysts at Week 16	Baseline and Week 16	—
Change From Baseline in Closed Comedones at Week 16	Baseline and Week 16	—
Change From Baseline in Open Comedones at Week 16	Baseline and Week 16	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Treated Group Pulsed Dye Laser Therapy and Untreated Group Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.	44
Total	44

Baseline characteristics

Characteristic	Treated Group Pulsed Dye Laser Therapy and Untreated Group
Age, Categorical <=18 years	1 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	43 Participants
Age, Continuous	25.41 years STANDARD_DEVIATION 8.46
Race/Ethnicity, Customized Asian	5 participants
Race/Ethnicity, Customized Black / African American	3 participants
Race/Ethnicity, Customized Caucasian	30 participants
Race/Ethnicity, Customized Hispanic, Latina	2 participants
Race/Ethnicity, Customized Middle Eastern	2 participants
Race/Ethnicity, Customized More than one race	1 participants
Race/Ethnicity, Customized Unknown	1 participants
Region of Enrollment United States	44 participants
Sex: Female, Male Female	30 Participants
Sex: Female, Male Male	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	5 / 44	0 / 44
serious Total, serious adverse events	0 / 44	0 / 44

Outcome results

Primary

Change From Baseline in Acne Severity at Week 10

The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Acne Severity at Week 10	Change from Baseline on Treated Side	-0.90 units on a scale
All Study Participants	Change From Baseline in Acne Severity at Week 10	Change from Baseline on Untreated Side	-0.30 units on a scale

Comparison: Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.003paired t-test, 2-sided

Primary

Change From Baseline in Closed Comedones at Week 10

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Closed Comedones at Week 10	Change from Baseline on Treated Side	-5.07 closed comedones
All Study Participants	Change From Baseline in Closed Comedones at Week 10	Change from Baseline on Untreated Side	-1.17 closed comedones

Comparison: Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.1paired t-test, 2-sided

Primary

Change From Baseline in Cysts at Week 10

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Cysts at Week 10	Change from Baseline on Treated Side	0.10 cysts
All Study Participants	Change From Baseline in Cysts at Week 10	Change from Baseline on Untreated Side	0.07 cysts

Comparison: Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.79paired t-test, 2-sided

Primary

Change From Baseline in Erythematous Macules at Week 10

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Erythematous Macules at Week 10	Change from Baseline on Treated Side	-1.88 erythematous macules
All Study Participants	Change From Baseline in Erythematous Macules at Week 10	Change from Baseline on Untreated Side	1.28 erythematous macules

Comparison: Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.02paired t-test, 2-sided

Primary

Change From Baseline in Open Comedones at Week 10

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Open Comedones at Week 10	Change from Baseline on Treated Side	-1.00 open comedones
All Study Participants	Change From Baseline in Open Comedones at Week 10	Change from Baseline on Untreated Side	-0.63 open comedones

Comparison: Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.73paired t-test, 2-sided

Primary

Change From Baseline in Papule Acne Lesions at Week 10

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Papule Acne Lesions at Week 10	Change from Baseline on Treated Side	-4.63 papule acne lesions
All Study Participants	Change From Baseline in Papule Acne Lesions at Week 10	Change from Baseline on Untreated Side	-0.13 papule acne lesions

Comparison: Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.01paired t-test, 2-sided

Primary

Change From Baseline in Pustule Acne Lesions at Week 10

Time frame: Baseline and Week 10

Arm	Measure	Group	Value (MEAN)
All Study Participants	Change From Baseline in Pustule Acne Lesions at Week 10	Change from Baseline on Treated Side	-1.80 pustule acne lesions
All Study Participants	Change From Baseline in Pustule Acne Lesions at Week 10	Change from Baseline on Untreated Side	-1.20 pustule acne lesions

Comparison: Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patientsp-value: 0.43paired t-test, 2-sided

Secondary

Change From Baseline in Acne Severity at Week 16

The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.