Photodynamic therapy with BF‐200 ALA for the treatment of actinic keratosis: results of a prospective,randomized, double‐blind,placebo‐controlled phase III study

Background Photodynamic therapy (PDT) with 5‐aminolaevulinic acid (ALA) provides a therapeutic option for the treatment of actinic keratosis (AK). Different strategies are applied to overcome the chemical instability of ALA in solution and to improve skin penetration. A new stable nanoemulsion‐based ALA formulation, BF‐200 ALA, is currently in clinical development for PDT of AK. Objectives To evaluate the efficacy and safety of PDT of AK with BF‐200 ALA. Methods The study was performed as a randomized, multicentre, double‐blind, placebo‐controlled, interindividual, two‐armed trial with BF‐200 ALA and placebo. A total of 122 patients with four to eight mild to moderate AK lesions on the face and/or the bald scalp were included in eight German study centres. The efficacy of BF‐200 ALA after one and two PDT treatments was evaluated. BF‐200 ALA was used in combination with two different light sources under illumination conditions defined by European competent authorities. Results PDT with BF‐200 ALA was superior to placebo PDT with respect to patient complete clearance rate (per‐protocol group: 64% vs. 11%; P < 0·0001) and lesion complete clearance rate (per‐protocol group: 81% vs. 22%) after the last PDT treatment. Statistically significant differences in the patient and lesion complete clearance rates and adverse effect profiles were observed for the two light sources, Aktilite^® CL128 and PhotoDyn^® 750, at both time points of assessment. The patient and lesion complete clearance rates after illumination with the Aktilite^® CL128 were 96% and 99%, respectively. Conclusions BF‐200 ALA is a very effective new formulation for the treatment of AK with PDT. Marked differences between the efficacies and adverse effects were observed for the different light sources used. Thus, PDT efficacy is dependent both on the drug and on the characteristics of the light source and the illumination conditions used.     

Long‐pulsed dye laser vs. intense pulsed light for the treatment of facial telangiectasias: a randomized controlled trial

Objective This study aims to compare the efficacy and adverse effects of long‐pulsed dye laser (LPDL) and intense pulsed light (IPL) in the treatment of facial telangiectasias. Methods We used intra‐individual, randomized, controlled trial with split‐face treatments and single‐blind outcome evaluations in this study. Forty patients with symmetrically located facial telangiectasias received a series of three LPDL (V‐beam, 595 nm, Candela Laser Corp.) and three IPL treatments (Ellipse Flex, PR and VL2 applicators, Danish Dermatologic Development) at 6‐week intervals. Patients were evaluated 3 months after the final treatment. Outcome measures were clinical efficacy (five‐point ordinal scale), pain (10‐point numerical scale), adverse effects, patient satisfaction (10‐point numerical scale) and preferred treatment. Results Thirty‐nine of 40 patients completed the study. All but 2 patients obtained a reduction in facial telangiectasias from both IPL and LPDL treatments. Both treatments were effective with good or excellent response in 30 of 39 patients. The LPDL was superior in the overall reduction of telangiectasias by blinded photographic evaluations: Excellent clearance (75% to 100% vessel clearance) was found in 18 patients treated with LPDL (46%) and in 11 patients treated with IPL (28%) (P = 0.01). Patients experienced less pain from LPDL [4 (2–6)] than IPL treatments [7 (3–9)] (P < 0.001). No adverse effects (hypo‐/hyperpigmentation or scarring) were seen from any of the treatments. Patients were satisfied with both LPDL [8 (2–10)] and IPL treatments [7 (2–10)] (P = 0.05). Twenty‐five patients preferred the LPDL (64%), 8 patients preferred IPL (21%) and 6 patients had no preference (15%) (P < 0.001). Conclusion This study was based on two specific types of laser and IPL equipment, which effectively clear telangiectasias; however, the most beneficial outcome was from the LPDL.     

Photodynamic therapy with intralesional 5-aminolevulinic acid and intense pulsed light versus intense pulsed light alone in the treatment of acne vulgaris: a comparative study

Despite the availability of many treatment modalities for acne vulgaris (AV), few of which provide excellent results. Photodynamic therapy (PDT) was shown to be an effective treatment especially when used with topical 5-aminolevulenic acid (ALA). We compared the efficacy and safety of PDT using intralesional ALA (IL-ALA) with intense pulsed light (IPL) and IPL alone in the treatment of AV. This study was carried on 30 patients with nodulocystic and inflammatory AV on the face and back. The right side of the body was treated with IL-ALA plus IPL, while the left side was treated with IPL alone. All patients experienced a reduction in number of acne lesions on both sides of the body, but the reduction was significantly more in PDT side than IPL only side. Recurrence of the lesions was significantly more likely in the IPL only side. There was no statistically significant difference between the face and back lesions in drug side effects and recurrence of the lesions. We concluded that photodynamic therapy in this cohort is effective in the treatment of AV when combined with IL-ALA. It gives superior results compared with IPL alone with minimal and tolerable side effects and less recurrence rates.     

Clinical effectiveness of intense pulsed light therapy for solar lentigines of the hands

Intense pulsed light (IPL) treatment, as a nonablative phototherapy, is known to improve various signs of facial photoaging skin, e.g., solar lentigines, fine wrinkles, and telangiectasias. The purpose of the present study was to investigate the efficacy and tolerability of IPL with a 515-nm filter in patients with solar lentigines on the back of hands. An open study was performed in 31 patients who were treated with a 1-month interval up to five times. Sixty-two percent of patients had more than 50% improvement and 23% had more than 75% improvement. No patients discontinued due to adverse effects, and no patients showed hyperpigmentation or scarring after the treatments. Phototherapy using this IPL source was effective and well tolerated in the patients, suggesting that this phototherapy may be an appropriate modality for the treatment of solar lentigines of the hands.     

Skin rejuvenation using intense pulsed light: a randomized controlled split-face trial with blinded response evaluation

OBJECTIVE: To evaluate efficacy and adverse effects of intense pulsed light rejuvenation in a homogeneous group of patients. DESIGN: Randomized controlled split-face trial. SETTING: University dermatology department. PATIENTS: Thirty-two female volunteers with Fitzpatrick skin type I through III and class I or II rhytids. INTERVENTIONS: Subjects were randomized to 3 intense pulsed light treatments at 1-month intervals or to no treatment of right or left sides of the face. MAIN OUTCOME MEASURES: Primary end points were skin texture and rhytids. Secondary end points were telangiectasia, irregular pigmentation, and adverse effects. Efficacy was evaluated by patient self-assessments and by blinded clinical and photographic evaluations up to 9 months after final treatment. Adverse effects were assessed clinically and by noninvasive skin reflectance measurements. RESULTS: Skin texture was significantly improved at all clinical assessments except at the 6-month examination (P<.006). The improvements peaked at 1 month after treatment, at which time 23 (82%) of 28 patients had better appearances of treated vs untreated sides. Most patients obtained mild or moderate improvements, and 16 patients (58%) self-reported mild or moderate efficacy on skin texture. Rhytids were not significantly different on treated vs untreated sides, and 19 patients (68%) reported uncertain or no efficacy on rhytids. Significant improvements of telangiectasia (P<.001) and irregular pigmentation (P<.03) were found at all assessments. Three patients withdrew from the study because of pain related to treatment. CONCLUSIONS: Three intense pulsed light treatments improved skin texture, telangiectasia, and irregular pigmentation but had no efficacy on rhytids. Adverse events were minimal, but included scar in 1 patient.     

Photodynamic therapy of actinic keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue light.

BACKGROUND: Aminolevulinic acid hydrochloride (ALA, Levulan) applied topically to actinic keratoses (AKs) leads to accumulation of the photosensitizer protoporphyrin IX, which, when activated by exposure to light, eradicates AKs. OBJECTIVE: We examined the safety and efficacy of photodynamic therapy using topical 20% ALA in a solution formulation and varying blue light doses to treat multiple AKs on the face and scalp. METHOD: This is a multicenter, investigator-blinded, randomized, vehicle-controlled study. RESULTS: Thirty-six patients with clinically typical AKs were treated with 20% ALA; 14 to 18 hours later, they were irradiated with a nonlaser fluorescent blue light source. With the optimal light dose of 10 J/cm(2), 88% of the AKs completely cleared 8 weeks after a single photodynamic treatment, compared with 6% after treatment with vehicle and light. CONCLUSION: Topical ALA PDT using a nonlaser, blue light source is an effective treatment for multiple AKs.     

Long-pulsed Nd:YAG laser vs. intense pulsed light for hair removal in dark skin: a randomized controlled trial

Background Although several lasers meet the wavelength criteria for selective follicular destruction, the treatment of darker skin phototypes is particularly challenging because absorption of laser energy by the targeted hairs is compromised by an increased concentration of epidermal melanin. Objectives To compare satisfaction level, safety and effectiveness of a long‐pulsed Nd:YAG laser and intense pulsed light (IPL) in axillary hair reduction in subjects with dark skin. Methods The study design was a within‐patient, right‐left, assessor‐blinded, comparison of long‐pulsed Nd:YAG laser and IPL. Fifty women (skin phototypes IV–VI) volunteered for removal of axillary hair. Five sessions at 4‐ to 6‐week intervals were performed. Hair counts at both sides were compared at baseline and 6 months after the last session. Final overall evaluations were performed by subjects and clinician at the end of the study. Satisfaction was scored for both devices. Results Thirty‐nine women completed the study. At 6 months, the decrease in hair counts on the laser side (79·4%, P < 0·001 vs. pretreatment) was significantly (P < 0·01) greater than that on the IPL side (54·4%, P < 0·01 vs. pretreatment). Only temporary adverse effects were reported at both sides. Higher pain scores and more inflammation were reported with Nd:YAG laser; however, it was preferred by 29 volunteers (74%). Volunteers reported higher satisfaction score with Nd:YAG laser (P < 0·01). Conclusions Dark skin can be treated by both systems safely and effectively; however, long‐pulsed (1064 nm) Nd:YAG laser is more effective as reported by both subjects and clinician.     

Variable pulsed light is less painful than light-emitting diodes for topical photodynamic therapy of actinic keratosis: a prospective randomized controlled trial

BACKGROUND: Photodynamic therapy (PDT) of actinic keratosis (AK) using methylaminolaevulinate (MAL) is an effective and safe treatment option, but the procedure is painful. OBJECTIVES: To evaluate the efficacy and pain associated with variable pulsed light (VPL), a prospective, randomized, controlled split-face study was performed. METHODS: Topical MAL-PDT was conducted in 25 patients with AK (n = 238) who were suitable for two-sided comparison. After incubation with MAL, irradiation was performed with a light-emitting diode (LED) (50 mW cm(-2); 37 J cm(-2)) vs. VPL (80 J cm(-2), double pulsed at 40 J cm(-2), pulse train of 15 impulses each with a duration of 5 ms, 610-950 nm filtered hand piece) followed by re-evaluation up to 3 months. RESULTS: The pain during and after therapy was significantly lower with VPL irradiation [t (d.f. = 24) = 4.42, P < 0.001]. The overall mean +/- SD infiltration and keratosis score at 3 months after treatment was 0.86 +/- 0.71 (LED system) vs. 1.05 +/- 0.74 (VPL device) (no statistically significant difference; P = 0.292). Patient satisfaction following both treatment modalities did not significantly differ at the 3-month follow up (P = 0.425). CONCLUSIONS: VPL used for MAL-PDT is an efficient alternative for the treatment of AK that results in complete remission and cosmesis equivalent to LED irradiation but causes significantly less pain.