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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04154436
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 36.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Skin Manifestations	Other: Sodium Bicarbonate (NaHCO3) Plus Solution; Other: Water (H2o)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 neutralizerSplit 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
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 17, 2019
• Actual Primary Completion Date: Nov 28, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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	Other: Sodium Bicarbonate (NaHCO3) Plus Solution; 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	Other: Water (H2o); Alkaline Solution

Outcome Measures

Primary Outcome Measures

1. Erythema degree [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

2. Erythema degree [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

3. Erythema degree [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

4. Erythema degree [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

5. Erythema degree [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

6. Pain Score [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

7. Pain Score [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

8. Pain Score [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

9. Pain Score [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

10. itch score [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

11. itch score [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

12. itch score [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

13. itch score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	dr. Cipto Mangunkusumo General Central National Hospital	Jakarta Pusat	DKI Jakarta	Indonesia

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: Irma B Sitohang, MD, Fakultas Kedokteran Universitas Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr.dr.Irma Bernadette, SpKK (K), Head of Cosmetic Division in Department of Dermatology and Venereology, Indonesia University
• ClinicalTrials.gov Identifier: NCT04154436
• Other Study ID Numbers: 19-06-0764
• First Posted: Nov 6, 2019
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Manifestations

Study Results

No Results Posted as of Apr 13, 2020