Skin Manifestations Clinical Trial
Official title:
Effectiveness, Safety, and Cost Efficacy of Water (H2O) as a Substitute for Sodium Bicarbonate (NaHCO3) Plus Solution in Neutralization of Chemical Peeling Using 35% Glycolic Acid Solution
Verified date | April 2020 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chemical peeling is an applied procedure which creates controlled destruction of all layers
of the epidermis or dermis, subsequently causes exfoliation followed by regeneration of
layers with the final result of improved texture and appearance of the skin. Various
indications of chemical peeling actions include damage to skin structure (skin aging, scars,
pigmentation disorders), superficial tumors (seborrheic keratosis, lentigo, actinic
keratosis), and inflammation such as acne vulgaris. Various chemicals commonly used for
procedures in peeling include alpha hydroxy acid or alpha-hydroxy acids (AHA) such as
Glycolic Acid (GA) 20−70%, lactic acid, malic acid, pyruvic acid; beta hydroxy acids / BHA
(10-30% salicylic acid), carbon dioxide snow, Jessner solution, lipohydroxy acid, resorcinol,
retinoic acid, trichloroacetic acid (TCA), phenols, Baker − Gordon formula. In this study,
the investigators are using glycolic acid 35% solution. Based on its mechanism of action,
glycolic acid (GA) is a keratolytic agents, in which it penetrates the stratum corneum and
interfere with corneocyte adhesion by damaging the intercellular desmosome bonds. Until now,
GA is a superficial peeling that is very popular and most widely used throughout the world .
The advantages of GA peeling include odorless, colorless, painless, permanently effective,
and minimal side effects. However, unlike non-AHA peeling materials, peels made from AHA
cannot be neutralized by themselves. Without neutralization, AHA will penetrate deeper and
may cause scars. Neutralization is the process of applying a base solution to stop the work
of chemicals in peeling. In neutralization, liquids that can be used are alkaline liquids
such as water, sodium bicarbonate, sodium hydroxide or ammonium saline solution to stop its
work. In various literature, it is stated that water can be used as a neutralizing liquid in
the chemical peels of AHA. It has also been mentioned in the literature that neutralization
with sodium bicarbonate on the market does not provide any advantage over water use, as long
as the acid is completely removed from the skin surface. The objective of this research is to
look into the effectiveness, safety , and cost efficacy of water (H2O).
Status | Completed |
Enrollment | 126 |
Est. completion date | December 31, 2019 |
Est. primary completion date | November 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. 18-60 years old, male or female, 2. Patients who visited the outpatient department of Cosmetic Dermatology Division in RSCM with almost symmetrical lesions and will undergo chemical peeling procedure using 35% glycolic acid solution 3. Patients who have received priming with minimal priming ingredients containing topical retinoic acid with a concentration of 0.025%; 0.05%; 0.1% for at least 2 weeks and has been discontinued for 1 - 3 days before chemical peeling procedure. 4. Patients who are willing to be the subject of research by signing a research consent letter after being given an explanation (informed consent) Exclusion Criteria: 1. Pregnancy, breastfeeding at the time of examination. 2. A history of systemic illness or in therapy for hormonal / endocrine disorders or other serious illnesses and / or in immunosuppressant therapy. 3. History of skin abnormalities due to photosensitivity, or allergic / severe complaints of side effects of drugs when priming. 4. History of atopy. 5. Difficulty in compliance following treatment |
Country | Name | City | State |
---|---|---|---|
Indonesia | dr. Cipto Mangunkusumo General Central National Hospital | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erythema degree | To measure the degree of erythema using Clinician Erythema Assessment (CEA) with a score ranging from 0 - 4 (0: clear skin (no erythema), 1 : almost clear (slight redness), 2 : mild erythema (definite redness) , 3: moderate erythema (marked redness), 4 : severe erythema(fiery redness) in the neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Initial assessment (minute 0) | |
Primary | Erythema degree | To measure the degree of erythema using Clinician Erythema Assessment (CEA) with a score ranging from 0 - 4 (0: clear skin (no erythema), 1 : almost clear (slight redness), 2 : mild erythema (definite redness) , 3: moderate erythema (marked redness), 4 : severe erythema(fiery redness) in the neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Right before neutralization (5 - 10 seconds before neutralization) | |
Primary | Erythema degree | To measure the degree of erythema using Clinician Erythema Assessment (CEA) with a score ranging from 0 - 4 (0: clear skin (no erythema), 1 : almost clear (slight redness), 2 : mild erythema (definite redness) , 3: moderate erythema (marked redness), 4 : severe erythema(fiery redness) in the neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Right after neutralization (5 - 10 seconds after neutralization | |
Primary | Erythema degree | To measure the degree of erythema using Clinician Erythema Assessment (CEA) with a score ranging from 0 - 4 (0: clear skin (no erythema), 1 : almost clear (slight redness), 2 : mild erythema (definite redness) , 3: moderate erythema (marked redness), 4 : severe erythema(fiery redness) in the neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | 15 minutes after neutralization | |
Primary | Erythema degree | To measure the degree of erythema using Clinician Erythema Assessment (CEA) with a score ranging from 0 - 4 (0: clear skin (no erythema), 1 : almost clear (slight redness), 2 : mild erythema (definite redness) , 3: moderate erythema (marked redness), 4 : severe erythema(fiery redness) in the neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | 30 minutes after neutralization | |
Primary | Pain Score | To measure the pain scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 (1 being the least painful , 10 means the most painful) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Right before Neutralization (5 - 10 seconds before neutralization) | |
Primary | Pain Score | To measure the pain scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 (1 being the least painful , 10 means the most painful) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Right after Neutralization (5 - 10 seconds after neutralization) | |
Primary | Pain Score | To measure the pain scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 (1 being the least painful , 10 means the most painful) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | 15 minutes after Neutralization | |
Primary | Pain Score | To measure the pain scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 (1 being the least painful , 10 means the most painful) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | 30 minutes after Neutralization | |
Primary | itch score | To measure the itch scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 ( 1 being the least itch, and 10 being the most itch) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Right before neutralization (5 - 10 seconds before neutralization) | |
Primary | itch score | To measure the itch scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 ( 1 being the least itch, and 10 being the most itch) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | Right after neutralization(5 - 10 seconds after neutralization) | |
Primary | itch score | To measure the itch scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 ( 1 being the least itch, and 10 being the most itch) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | 15 minutes after neutralization | |
Primary | itch score | To measure the itch scores by Visual Analogue Score (VAS), with a score ranging from 1 - 10 ( 1 being the least itch, and 10 being the most itch) on neutralization of GA 35% peeling using water (H2O) in comparison to sodium bicarbonate (NaHCO3) plus solution | 30 minutes after neutralization |
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