Linkner 2014.
| Methods | A split‐face, single‐centre, randomised double‐blinded study | |
| Participants | 5 healthy adult women (age range 36 ‐ 46 years) with either ice pick, rolling, or boxcar atrophic moderate‐to‐severe acne scars on the face Exclusion: "Females who were pregnant, breastfeeding, or attempting to conceive were excluded as well as those with a history of known or suspected intolerance to any of the excipients of ALA or any of its vehicle components. Subjects with a history of cutaneous photosensitization (including porphyria or systemic lupus erythematosus), active skin malignancy or infection, and those taking any photo sensitizing medications. All medications, topical and oral, known to alter the course of acne scarring or acne vulgaris taken within two weeks of initiation or during the study period were prohibited." |
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| Interventions | Intervention: "A solution of 20% δ‐aminolevulinic acid (commercially available as Levulan Kerastick, Dusa: ALA‐PDT) was applied topically to either the right or left sides of the face for a 60‐minute incubation period after microdermabrasion. After incubation, lesions were illuminated with 417nm blue light (Blu‐U Blue Light Photodynamic Therapy Illuminator) with irradiance of 10mW/cm2 for 1,000 seconds, with a total light dose of 10J/cm2. A therapeutic course of five consecutive treatments four weeks apart was used." Comparator: "A vehicle solution alone (vehicle‐PDT, supplied by Dusa) was applied topically to the other side of the face for a 60‐minute incubation period after microdermabrasion. After incubation, lesions were illuminated with 417nm blue light (Blu‐U Blue Light Photodynamic Therapy Illuminator) with irradiance of 10mW/cm2 for 1,000 seconds, with a total light dose of 10J/cm2. A therapeutic course of five consecutive treatments four weeks apart was used." |
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| Outcomes | Improvement of acne scars (4 months), using the Physician’s Global Assessment of Acne Scarring scale. Timing: at baseline, week 4, week 8, week 12, week 16 Participant satisfaction (4 months) using patient questionnaire Side effects (5 months) using a 10‐point scale (0 = none; 1 – 3 = mild; 4 – 6 = moderate; 7 – 9 = severe). Timing: during and immediately after each treatment | |
| Funding source | No funding source | |
| Declaration of interest | Nothing to be declared | |
| Notes | USA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects with moderate‐to‐severe acne scarring who were randomly assigned" Comment: Insufficient data |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information about the allocation concealment process to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "A double‐blinded study" Comment: Probably done |
| Blinding of outcome assessment (detection bias) Investigator‐ assessed | Low risk | Quote: "Two blinded assessors reviewed pretreatment and end‐of‐study split‐ and full‐face photographs taken at each visit and evaluated acne scar severity" Comment: Probably done |
| Blinding of outcome assessment (detection bias) Participant‐reported | Low risk | Quote: "A double‐blinded study" Comment: Probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 participants were enrolled with 5 completing the study |
| Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes that are of interest in the review |
| Other bias | Low risk | The study appears to be free of other sources of bias |