An interventional study of CO2 Fractional Laser and Hydrogel in Hydration, Carbon-dioxide Laser and Laser Therapy, sponsored by Dr.dr.Irma Bernadette, SpKK (K). Not yet recruiting at 1 site in Indonesia. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Dr.dr.Irma Bernadette, SpKK (K) · Not applicable, Interventional, and Treatment
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).
Dr.dr.Irma Bernadette, SpKK (K) is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.
Also known as: laser treatment
Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.
Placebo gel matched in appearance and application method to the investigational hydrating gel.
Skin Hydration
Skin hydration will be evaluated by measuring skin capacitance using a corneometer.
Time frame: 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.
Time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Erythema severity
Change in erythema severity assessed by dermatologist evaluation.
Time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Subjective assessment
Anamnesis, VAS (Visual Analog Scale) Score
Time frame: Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.
Start is estimated for Jun 2026; primary completion for Jul 2026, 1 month later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Dr.dr.Irma Bernadette, SpKK (K)