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| Name | Class |
|---|---|
| Cavalca & Cortelli private research center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melasma TCA associated with croton oil peel | Experimental | 3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation |
|
| Melasma isolate TCA peel | Active Comparator | 3 sections every 30 days of a chemical peel containing only 35% TCA |
|
| Melasma Laser ND-YAG laser | Active Comparator | 3 sections every 30 days of Neodymium: yttrium-aluminum-garnet (ND-YAG) laser |
|
| Acne scars TCA associated with croton oil peel | Experimental | 3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation |
|
| Acne scars isolate TCA peel | Active Comparator | 3 sections every 30 days of a chemical peel containing only 35% TCA |
|
| Acne scars Er-YAG laser |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 35% TCA combined with croton oil peel | Procedure | 3 sections every 30 days of 35% TCA combined with croton oil peel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glogau scale | Changes in Glogau scale (I to IV) for rejuvenation group. Higher values indicate worse aging conditions. | Baseline, 3 and 6 months |
| Melasma index | Changes in 1 to 6 scores of modified Melasma Area and Severity Index (mMASI). Higher values indicate worse melasma conditions. | baseline versus 3 months after treatment |
| Acne Scars Index | Changes in Global 1 to 5 Scale for Acne Scar Severity (SCAR-S). Higher values indicate worse acne scars conditions. | Baseline versus 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment impact on Quality of life | SKINDEX-16 scores (0 to 100) after treatment. Higher values indicate worse quality of life. | Baseline versus immediate post-treatment |
| Patient's satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported pain | Evaluation by a 10 point Visual Analogue Scale. Higher values indicate worse pain experience. | Days 0, 30 and 60. |
| Adverse Events | Self-reported and diagnosed adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila C Cortelli, Doctorate | University of Taubate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cavalca & Cortelli Research Center | Taubaté | São Paulo | 12010-700 | Brazil | ||
| University of Taubate Dental School |
Only not identified data will be shared within research team.
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Statistics staff
| Active Comparator |
3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser |
|
| Facial rejuvenation TCA associated with croton oil peel | Experimental | 3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation |
|
| Facial rejuvenation isolate 35% TCA peel | Active Comparator | 3 sections every 30 days of a chemical peel containing only 35% TCA |
|
| Facial wrinkles Er-YAG laser | Active Comparator | 3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser |
|
| Isolate 35% TCA peel | Procedure | 3 sections every 30 days of isolate 35% TCA peel |
|
| Erbium-YAG laser | Radiation | 3 sections every 30 days of Er-YAG laser |
|
| Neodymium -YAG laser Q-switched | Radiation | 3 sections every 30 days of ND-YAG laser |
|
Evaluation of Patient Global Assessment (PtGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best patient's satisfaction.
| Immediate post-treatment |
| Professional's satisfaction | Evaluation of Physician Global Assessment (PGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best professional's satisfaction. | 3 months after treatment |
| Baseline versus 12 months after treatment |
| LINE-1 | Changes in DNA methylation (5-meC), hydroxymethylation (5-hmeC) and 5-meC/5-hmeC ratio in the promoter region of LINE-1 elements | baseline vs. 6 months |
| Taubaté |
| São Paulo |
| 12020-330 |
| Brazil |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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