HydrationNCT07639151
Effectiveness and Safety of a Hydrating Gel Containing Polyvinyl Pyrrolidine, Algin and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy
A study testing CO2 Fractional Laser and Hydrogel in people with Hydration and Carbon-dioxide Laser, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hydration, Carbon-dioxide Laser, Laser Therapy
- What is being tested?
- CO2 Fractional Laser and Hydrogel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Indonesia Hospital
Depok, West Java
Irma Bernadette S. Sitohang, Prof. Dr. dr., +62818130761, irma_bernadette@yahoo.com
Irma Bernadette S. Sitohang, Prof. Dr. dr.
About this study
Official title: Effectiveness and Safety of a Hydrating Gel Containing Aqua, Carrageenan, Polyvinyl Pyrrolidon, Algin, Gellan Gum, and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy
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
- Being tested
- CO2 Fractional Laser, Hydrogel, Placebo gel
- Keywords
- Hydrogel, CO2 Fractional Laser, Hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 Fractional LaserDevice
Also called laser treatment
Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.
HydrogelOther
Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.
Placebo gelOther
Placebo gel matched in appearance and application method to the investigational hydrating gel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Hydration
Skin hydration will be evaluated by measuring skin capacitance using a corneometer.
Measured: 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.
Measured: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Secondary outcomes (2)
Erythema severity
Change in erythema severity assessed by dermatologist evaluation.
Measured: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Subjective assessment
Anamnesis, VAS (Visual Analog Scale) Score
Measured: Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesian Society of Dermatology and Venereology, College of Dermatologist and Venereologist, Indonesia Medical Education and Research Institute
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma Bernadette S. Sitohang, Prof. Dr. dr., Principal investigator, Universitas Indonesia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639151
- Sponsor's protocol ID
- Hydrogel
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of a Hydrating Gel Containing Aqua, Carrageenan, Polyvinyl Pyrrolidon, Algin, Gellan Gum, and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy
- ClinicalTrials.gov ID
- NCT07639151
- Acronym / sponsor ID
- Hydrogel
- Conditions
- Hydration, Carbon-dioxide Laser, Laser Therapy, Hydrogel
- Keywords
- Hydrogel, CO2 Fractional Laser, Hydration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Collaborators
- Indonesian Society of Dermatology and Venereology, College of Dermatologist and Venereologist, Indonesia Medical Education and Research Institute
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser + Hydrogel | Experimental | Device: CO2 Fractional Laser, Other: HydrogelParticipants 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. |
| Fractional CO₂ Laser + Placebo | Placebo comparator | Device: CO2 Fractional Laser, Other: Placebo gelParticipants will undergo fractional CO₂ laser treatment followed by application of a placebo gel according to the study protocol. |
| Hydrating Gel Only | Experimental | Other: HydrogelParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 Fractional LaserAlso: laser treatmentFractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist. | Device | Fractional CO₂ Laser + Placebo, Laser + Hydrogel |
| HydrogelHydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid. | Other | Hydrating Gel Only, Laser + Hydrogel |
| Placebo gelPlacebo gel matched in appearance and application method to the investigational hydrating gel. | Other | Fractional CO₂ Laser + Placebo |
Primary outcome
Skin Hydration
Time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Skin hydration will be evaluated by measuring skin capacitance using a corneometer.
Dermoscopic Assessment of Skin Recovery
Time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Dermoscopic evaluation of post-treatment skin changes and recovery.
2 secondary outcomes
Erythema severity
Time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Subjective assessment
Time frame: Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irma Bernadette S. Sitohang, Prof. Dr. dr. principal investigator
Universitas Indonesia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 Fractional Laser and Hydrogel in people with Hydration and Carbon-dioxide Laser, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma Bernadette S. Sitohang, Prof. Dr. dr. (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Hydration (time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.