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

NCT ID: NCT04154436

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Sodium Bicarbonate (NaHCO3) Plus Solution

Intervention Type: OTHER

Alkaline Solution

Water (H2O)

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

Group Type: PLACEBO_COMPARATOR

Water (H2o)

Intervention Type: OTHER

Alkaline Solution

Interventions

Sodium Bicarbonate (NaHCO3) Plus Solution

Alkaline Solution

Intervention Type: OTHER

Water (H2o)

Alkaline Solution

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dr.dr.Irma Bernadette, SpKK (K)

Head of Cosmetic Division in Department of Dermatology and Venereology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irma B Sitohang, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

dr. Cipto Mangunkusumo General Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

19-06-0764

Identifier Type: -

Identifier Source: org_study_id