Effectiveness and Safety of a Hydrating Gel Containing Polyvinyl Pyrrolidine, Algin and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy

NCT07639151 | Not Yet Recruiting

• 1 other identifier: Hydrogel
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this interventional study is to evaluate the effectiveness and safety of a hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid. The study will assess the gel's ability to support optimal skin recovery following fractional CO₂ laser therapy and its effectiveness and safety as a daily adjunctive skincare treatment. Outcomes related to skin hydration, skin barrier function, tolerability, and adverse events will be evaluated throughout the study period. Female participants aged 18 to 60 years who provide informed consent will be enrolled in this study. Participants will undergo a 2-week priming period with topical tretinoin prior to fractional CO₂ laser treatment. Clinical evaluations will be performed at baseline, immediately after the laser procedure, and on Days 3, 7, and 14 post-treatment. Assessments conducted by a board-certified dermatologist will include dermoscopy, TEWAmeter assessment, erythema assessment, and evaluation of pain and discomfort using a Visual Analog Scale (VAS).

Conditions

Hydration; Carbon-dioxide Laser; Laser Therapy; Hydrogel

Keywords

Hydrogel; CO2 Fractional Laser; Hydration

Outcome Measures

Primary Outcomes (2)

• Skin Hydration

  Skin hydration will be evaluated by measuring skin capacitance using a corneometer.

  Baseline, immediately after treatment, Day 3, Day 7, and Day 14.

• Dermoscopic Assessment of Skin Recovery

  Dermoscopic evaluation of post-treatment skin changes and recovery.

  Baseline, immediately after treatment, Day 3, Day 7, and Day 14.

Secondary Outcomes (2)

• Erythema severity

  Baseline, immediately after treatment, Day 3, Day 7, and Day 14.

• Subjective assessment

  Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.

Study Arms (3)

Laser + Hydrogel

EXPERIMENTAL

Participants will undergo fractional CO₂ laser treatment followed by application of the hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid according to the study protocol.

Device: CO2 Fractional Laser; Other: Hydrogel

Fractional CO₂ Laser + Placebo

PLACEBO COMPARATOR

Participants will undergo fractional CO₂ laser treatment followed by application of a placebo gel according to the study protocol.

Device: CO2 Fractional Laser; Other: Placebo gel

Hydrating Gel Only

EXPERIMENTAL

Participants will receive the hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid without fractional CO₂ laser treatment according to the study protocol.

Other: Hydrogel

Interventions

CO2 Fractional Laser DEVICE

Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.

Also known as: laser treatment

Fractional CO₂ Laser + Placebo; Laser + Hydrogel

Hydrogel OTHER

Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.

Hydrating Gel Only; Laser + Hydrogel

Placebo gel OTHER

Placebo gel matched in appearance and application method to the investigational hydrating gel.

Fractional CO₂ Laser + Placebo

Eligibility Criteria

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

You may qualify if:

• Female participants aged 18-60 years.
• Patients attending the Dermatology and Venereology Outpatient Clinic of Universitas Indonesia Hospital (RSUI) who will receive the hydrating gel either following fractional CO₂ laser treatment or without undergoing the fractional CO₂ laser procedure.
• Patients who will undergo or have undergone a priming regimen with topical retinoic acid preparations at concentrations of at least 0.025%, 0.05%, or 0.1% for at least 2 weeks prior to fractional CO₂ laser treatment, or prior to study participation in the non-laser group.
• Willing to participate in the study and have provided written informed consent after receiving adequate explanation regarding the study.

You may not qualify if:

• Pregnant, breastfeeding, or currently using oral contraceptives at the time of assessment.
• History of systemic retinoid use within the past 3 months.
• History of or current treatment for hormonal/endocrine disorders or other serious medical conditions.
• Currently receiving immunosuppressive therapy.
• Participants who are unable or unwilling to comply with the study protocol and treatment regimen.

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead
• Indonesian Society of Dermatology and Venereology: collaborator
• College of Dermatologist and Venereologist: collaborator
• Indonesia Medical Education and Research Institute: collaborator

Study Sites (1)

Universitas Indonesia Hospital

Depok, West Java, Indonesia

Location

MeSH Terms

Interventions

Laser Therapy; Hydrogels

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Irma Bernadette S. Sitohang, Prof. Dr. dr.

  Universitas Indonesia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma Bernadette S. Sitohang, Prof. Dr. dr.

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr. Irma Bernadette S., SpDVE, Subsp D.K.E

Model Details: Participants will be randomized into one of three parallel groups: (1) fractional CO₂ laser therapy followed by hydrating gel application, (2) fractional CO₂ laser therapy followed by placebo application, or (3) hydrating gel application without fractional CO₂ laser therapy. Participants will remain in their assigned group throughout the study period and will undergo scheduled assessments at baseline and follow-up visits.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

ID (1)