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

NCT04154436 | Completed

• 1 other identifier: 19-06-0764
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Skin Manifestations

Outcome Measures

Primary Outcomes (13)

• 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)

• 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)

• 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

• 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

• 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

• 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)

• 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)

• 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

• 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

• 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)

• 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)

• 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

• 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

Study Arms (2)

Sodium Bicarbonate (NaHCO3) Plus Solution

EXPERIMENTAL

15 cc of Sodium Bicarbonate (NaHCO3) plus Solution will be sprayed on left or right side of the patient's face based on randomisation

Other: Sodium Bicarbonate (NaHCO3) Plus Solution

Water (H2O)

PLACEBO COMPARATOR

15 cc of Water (H2O) will be sprayed on the left or right side of the patient's face based on randomisation

Other: Water (H2o)

Interventions

Sodium Bicarbonate (NaHCO3) Plus Solution OTHER

Alkaline Solution

Sodium Bicarbonate (NaHCO3) Plus Solution

Water (H2o) OTHER

Alkaline Solution

Water (H2O)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

dr. Cipto Mangunkusumo General Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Skin Manifestations

Interventions

Sodium Bicarbonate; Water

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Irma B Sitohang, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and outcomes assessor will be masked in regards to which part of the face that the participant will receive water/sodium bicarbonate as neutralizing agent after chemical peeling
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cosmetic Division in Department of Dermatology and Venereology

Model Details: Split Face Left Side of the face will be given water / sodium bicarbonate as neutralizer Right Side of the face will be given water/ sodium bicarbonate as neutralizer

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 6, 2019
• Study Start: September 17, 2019
• Primary Completion: November 28, 2019
• Study Completion: December 31, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

ID (1)