Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine

About this trial

The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring

Subject must voluntarily sign and date an IRB approved informed consent form

Subjects with diagnosis of acne scarring recorded over the past 6 months

Able to read, understand and voluntarily provide written informed consent.

Disqualifiers

Subjects does not have the capacity to consent to the study

subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study

Subject has active papulopustular or cystic acne within the past 6 months.

Any history of keloidal scarring.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sciton Halo

    Device

    Laser treatment

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Hybrid Fractional laser - SOCExperimental treatment 1 intervention
Group B: Hybrid Fractional laser- Non- SOCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline acne scar severity

2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.

Time frame
month 3
2

Change from baseline acne scar severity

2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.

Time frame
month 5
3

Change from baseline acne scar severity

2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.

Time frame
month 8
4

Baseline Patient Satisfaction

Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.

Time frame
month 0 (patient consultation visit )

Secondary outcomes

Other outcomes

Sponsors and contacts

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