- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154436
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia
- dr. Cipto Mangunkusumo General Central National Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-60 years old, male or female,
- 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
- 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.
- 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:
- Pregnancy, breastfeeding at the time of examination.
- A history of systemic illness or in therapy for hormonal / endocrine disorders or other serious illnesses and / or in immunosuppressant therapy.
- History of skin abnormalities due to photosensitivity, or allergic / severe complaints of side effects of drugs when priming.
- History of atopy.
- Difficulty in compliance following treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sodium Bicarbonate (NaHCO3) Plus Solution
15 cc of Sodium Bicarbonate (NaHCO3) plus Solution will be sprayed on left or right side of the patient's face based on randomisation
|
Alkaline Solution
|
Placebo Comparator: Water (H2O)
15 cc of Water (H2O) will be sprayed on the left or right side of the patient's face based on randomisation
|
Alkaline Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema degree
Time Frame: Initial assessment (minute 0)
|
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)
|
Erythema degree
Time Frame: Right before neutralization (5 - 10 seconds before neutralization)
|
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)
|
Erythema degree
Time Frame: Right after neutralization (5 - 10 seconds after neutralization
|
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
|
Erythema degree
Time Frame: 15 minutes after neutralization
|
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
|
Erythema degree
Time Frame: 30 minutes after neutralization
|
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
|
Pain Score
Time Frame: Right before Neutralization (5 - 10 seconds before neutralization)
|
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)
|
Pain Score
Time Frame: Right after Neutralization (5 - 10 seconds after neutralization)
|
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)
|
Pain Score
Time Frame: 15 minutes after Neutralization
|
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
|
Pain Score
Time Frame: 30 minutes after Neutralization
|
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
|
itch score
Time Frame: Right before neutralization (5 - 10 seconds before neutralization)
|
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)
|
itch score
Time Frame: Right after neutralization(5 - 10 seconds after neutralization)
|
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)
|
itch score
Time Frame: 15 minutes after neutralization
|
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
|
itch score
Time Frame: 30 minutes after neutralization
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irma B Sitohang, MD, Fakultas Kedokteran Universitas Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-06-0764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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