Faghihi 2015.
| Methods | A randomised splitface clinical trial | |
| Participants | 42 Iranian patients aged 18 – 55 years Inclusion: "Fitzpatrick skin types III to IV and moderate to severe atrophic acne scars on both cheeks" Exclusion: "Pregnancy, lactation, active inflammatory acne, Immunocompetence, history of deep chemical peeling or filler injection in the previous 6 months, history of hypertrophic scars and keloids, use of isotretinoin in the previous 6 months, allergy to anaesthesia, active infection in the treatment area, pre‐malignant or malignant lesions in the treatment area, bleeding tendencies, and history of herpes simplex or herpes zoster infection on the face". |
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| Interventions | Intervention: 1 side of the participant's face was treated using the 10600nm fractional CO₂ laser alone (M×7000/Stamp Type, Daeshin, South Korea) Comparator: The other side of the face was treated with the same fractional CO₂ laser plus punch elevation (2.5 – 3 mm biopsy disposable punches) |
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| Outcomes | Improvement of acne scars (4 months), using a grading scale as follows: 1 = < 25% (minimal) improvement; 2 = 25% – 50% (moderate) improvement; 3 = 51% – 75% (good) improvement; 4 = > 75% (excellent) improvement Participant satisfaction (4 months), using a VAS; (rating of 0 was no satisfaction, and a rating of 10 was the best possible satisfaction) Side effects (4 months) Timing: 1 and 4 months after the second treatment session |
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| Funding source | Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran | |
| Declaration of interest | Nothing to be declared | |
| Notes | Iran The Isfahan University of Medical Sciences Ethical Committee, Isfahan, Iran, approved the study protocol. The trial was registered in the Iranian Registry of Clinical Trials: IRCT2014080218647N1. Note: trial was registered after the start of the trial Participants signed an informed consent form for participation in the study. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Using random allocation software" Comment: Probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "The assignment sequence was concealed in opaque envelopes." Comment: Probably done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "One side received fractional CO laser treatment and the other received one session of punch elevation combined with two sessions of laser fractional CO laser treatment" Comment: Probably not done. Given that the control arm was easily distinguished from the treatment arm during treatment, participants and the treating dermatologist were not blinded |
| Blinding of outcome assessment (detection bias) Investigator‐ assessed | Low risk | Quote: "Two dermatologists blinded to treatment side evaluated clinical improvement of acne scars." Comment: Probably done |
| Blinding of outcome assessment (detection bias) Participant‐reported | High risk | Quote: "One side received fractional CO laser treatment and the other received one session of punch elevation combined with two sessions of laser fractional CO laser treatment" Comment: No blinding of participants and the outcome assessment is likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 42 participants (100%) completed the 2 treatment sessions, and all were followed up for 4 months after the last treatment session |
| Selective reporting (reporting bias) | Low risk | The study protocol is available and all of the study's prespecified outcomes that are of interest in the review have been reported in the prespecified way |
| Other bias | Low risk | The study appears to be free of other sources of bias |