Acne Scars - Mixed Atrophic and Hypertrophic, Melasma, Rejuvenation, Resurfacing
Conditions
Keywords
chemical peel, Er-YAG, ND-YAG, fractional laser, home care
Brief summary
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This study will evaluate the effects of chemical peels with 35% TCA (trichloroacetic acid) and two types of fractional laser in orofacial harmonization procedures. A sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40) will be recruited to underwent 3 consecutive treatment sections every 30 days. Besides clinical improvements, global satisfaction scale of the professional and the patient will be measured in addition to the impact of the treatment on the quality of life of the participants and the sensory experience in relation to pain. Pre- and pos-peeling home care will be provided to measure whether they influence results or not. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.
Detailed description
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This randomized clinical trial will evaluate the effects of chemical peel with 35% TCA (trichloroacetic acid)associated with croton oil. And to compare the results with its isolated formulation containing only 35% TCA and with two types of fractional laser (2940nm Er-YAG and 1640nm Nd-YAG) in orofacial harmonization procedures. This study will be based on a sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40). The experimental times will be day -15 (pre-treatment), day 0 (1st treatment session), day 30 (2nd treatment session), day 60 (3rd treatment session), day 70 (immediate post-treatment) and day 120 (mediate post-treatment). The primary outcomes will be the difference (pre- versus post-peeling) in the scores of Melasma (mMASI), acne scars (SCAR-S) or facial wrinkles (Glogau index), in the respective groups according to the main complaints. As secondary outcomes, the global satisfaction scale of the professional (PGA) and the patient (PtGA) will be measured; the impact of the treatment on the quality of life of the participants (SKINDEX-16) and the sensory experience in relation to pain (EVA 1 to 10). All participants, under local anesthesia (button anesthesia), will be randomized into one of three treatment groups: 35% TCA associated with croton oil (test), 35% TCA alone, Er-Yag or Nd-YAG laser (comparators). Intra- and inter-group differences will be considered statistically significant when p \< 0.05. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.
Interventions
PROCEDURE35% TCA combined with croton oil peel
3 sections every 30 days of 35% TCA combined with croton oil peel
PROCEDUREIsolate 35% TCA peel
3 sections every 30 days of isolate 35% TCA peel
RADIATIONErbium-YAG laser
3 sections every 30 days of Er-YAG laser
RADIATIONNeodymium -YAG laser Q-switched
3 sections every 30 days of ND-YAG laser
Sponsors
Jose Roberto Cortelli
Cavalca & Cortelli private research center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistics staff
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women * aged 18 or over * acne scars, melasma or clear signs of photoaging and evident wrinkles * participants with acne scars or melasma will be included if they have never undergone treatment or if previous treatment has been ineffective.
Exclusion criteria
* phototype VI * autoimmune and dermatological diseases * known allergies to the components of the formulations * patients who prefer other treatment options * history of keloids * pregnant women * breastfeeding women * women of childbearing age who do not adopt a valid method of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glogau scale | Baseline, 3 and 6 months | Changes in Glogau scale (I to IV) for rejuvenation group. Higher values indicate worse aging conditions. |
| Melasma index | baseline versus 3 months after treatment | Changes in 1 to 6 scores of modified Melasma Area and Severity Index (mMASI). Higher values indicate worse melasma conditions. |
| Acne Scars Index | Baseline versus 3 months after treatment | Changes in Global 1 to 5 Scale for Acne Scar Severity (SCAR-S). Higher values indicate worse acne scars conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment impact on Quality of life | Baseline versus immediate post-treatment | SKINDEX-16 scores (0 to 100) after treatment. Higher values indicate worse quality of life. |
| Patient's satisfaction | Immediate post-treatment | Evaluation of Patient Global Assessment (PtGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best patient's satisfaction. |
| Professional's satisfaction | 3 months after treatment | Evaluation of Physician Global Assessment (PGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best professional's satisfaction. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORSheila C Cortelli, Doctorate
University of Taubate
Outcome results
None listed