TABLE 1.
Summary of the dermatologic uses of PL and the supporting clinical studies
| DERMATOLOGIC CONDITION | AUTHOR (DATE) | NUMBER OF SUBJECTS (AGE RANGE) | DOSING | PROPOSED MOA | OUTCOME (P<0.05) |
|---|---|---|---|---|---|
| Acute chemophoto-protection (UV) | Middelkamp-Hup et al (2004) | Nine subjects (Fitzpatrick 2–3) | 7.5mg/kg prior to sun exposure (480mg/d) | Antioxidant, immunoprotective, anti-inflammatory | Decrease in erythema in PL treated skin at 24 hours (p<0.01). Biopsy showed less sun-burned cells (p<0.05), less CPDs (p<0.001), less epidermal proliferation (p<0.01), and less mast cell infiltration (p<0.05) |
| Kohli et al (2017) | 22 subjects ((Fitzpatrick 1–3) | 240mg one hour, 240mg two hours prior to UVB irradiation (480mg/d) | Colorimetry: decrease in relative erythema intensity (p<0.05) Histologic reduction UVB biomarkers (p<0.05) | ||
| Photoaging and skin cancer | Villa et al (2010) | 10 subjects (29–54 years old) | 240mg PL 8 and two hours before UVA | Antioxidant, immunoprotective, anti-inflammatory, ECM regulation | Decrease in CB by 84 percent with PL (p=0.06) |
| Actinic Keratosis (AK) | Auriemma et al (2015) | 35 men with baldness and 2+ AKs | 960mg/d every month; 480mg/d every five months | Immunoprotective, photoprotective | Decreased recurrence of AK following PDT treatment (p=0.04) |
| Vitiligo | Reyes et al (2006) | 19 subjects | 720mg/d + PUVA | Antioxidant, immunoprotective, photoprotective | More PL + PUVA patients achieved 50 percent or greater repigmentation compared with placebo + PUVA (p<0.01) |
| Pacifico, 2009 (poster) | 50 subjects with generalized vitiligo | Six months: 29 subjects PL 480mg every day + NB-UVB; 28 subjects placebo + NB-UVB | PL + NB-UVB increased repigmentation (p<0.0005). Time to repigmentation was 1 month (PL) versus 3 months placebo | ||
| Middelkamp-Hup et al (2007) | 50 subjects with vitiligo | 250mg PO tid +NB-UVB biweekly for 25 to 26 weeks | Subjects with 80 percent attendance or more to NB-UVB + PL 50 percent repigmentation versus 19 percent placebo (p<0.002) | ||
| Melasma | Ahmed et al (2013) | 33 Hispanic females with melasma | 240mg PL tid for 12 weeks + topical SPF 55 | Photoprotective | 5.1 difference in melanin index (p=0.14). No statistical significance in MASI scores (p=0.62) |
| 33 Asian females from Singapore with melasma | 480mg PL at 8 am and 1 pm for 12 weeks + topical hydroquinone and SPF 50+ | mMASi and MelasQol scores reduced (p<0.05). Failed to find significant difference in melanin index score | |||
| 21 female subjects, aged 18 to 50, with epidermal melasma | PL 240mg PO bid + SPF 45 daily for 12 weeks | Statistically significant decrease in MASI scores in PL (p<0.05) | |||
| PMLE/Solar urticaria | Tanew et al (2012) | 30 subjects with severe PMLE | <55kg: 720mg qd 56 to 70kg: 960mg qd >70kg: 1200mg qd | Antioxidant, photoprotective, immunoprotective | No PMLE lesions in 30 percent and 28 percent exposed to UVA and UVB, respectfully. Increase in mean number of UVA and UVB irradiations to elicit PMLE (p=0.005; p=0.047) |
| Caccialanza et al (2007) | 26 subjects (19 female; 9 male), ages 21 to 68, with severe PMLE | PL 480mg qd (7.5mg/kg a day) | Significant decrease (p<0.05) | ||
| Caccialanza et al (2012) | 53 subjects with severe PMLE; four with solar urticaria | 480mg/d PO | 73.68-percent improvement (p<0.05) | ||
| High-risk patients with MM | Aguilera et al (2013) | 61 subjects | 240mg every 8 hours for one day and 360mg 3 hours before MED | Photoprotection, antioxidant | Reduction of UVB-MED values (p<0.005) |
| Atopic Dermatitis | Romirez-Rosca et al (2012) | 105 subjects, ages 2 to 17, with atopic dermatitis | Topical CS + age <6 years: 240mg/d 6 to 12 years: 360mg/d >12 years: 480mg/d | Antioxidant, immunoprotective | No significant decrease in CS use, but there was a significant decrease of antihistamine use (p=0.038) |
| SCLE | Breithaupt and Jacob (2012) | 1 subject moderately controlled on hydroxychloroquine | 240mg/d PL + hydroxychloroquine | Immunoprotective, antioxidant | Achieved near total remission |
| PCT | Hatch et al (2017) | 1 subject with PCT on hemodialysis | 240mg/d PO + hydroxychloroquine, topical CS, and mupirocin | Antioxidant, photoprotective | “Dramatic improvement” |