Xerosis CutisPhase 3NCT06178367
Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment
A Phase 3 study testing Low molecular weight hyaluronic acid and High molecular weight hyaluronic acid in people with Xerosis Cutis, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa) hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of xerotic skin in elderly Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Xerosis Cutis
- What is being tested?
- Low molecular weight hyaluronic acid and High molecular weight hyaluronic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Aug 2023to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male diagnosed with xerotic skin
- 60-80 years old
- Willing to participate in clinical trial and sign informed consent
Who cannot join
- History of hypersensitivity to moisturizer
- Dermatitis or any dermatosis on intervention area in the leg
- Score of erythema and crack more than 2, based on SRRC scoring
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Panti Sosial Tresna Werdha Budi Mulia 3
Jakarta, DKI Jakarta, 12420
About this study
Official title: Effectiveness and Safety Comparison Between Moisturizers Containing Low Molecular Weight Hyaluronic Acid, High Molecular Weight Hyaluronic Acid, and Vehicle on Skin Hydration in the Elderly With Xerotic Skin
The goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa) hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of xerotic skin in elderly
Read the detailed description
This clinical trial is conducted to compare the effectiveness and safety between moisturizers containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic acid, and its vehicle on skin hydration of elderly with xerotic skin. It is designed to answer following questions:
- Is the skin capacitance in the elderly after using moisturizers containing low molecular weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle?
- Is the transepidermal water loss in the elderly after using moisturizers containing high molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and vehicle?
- Is the dry skin score (SRRC) in the elderly after using moisturizers containing low molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and vehicle?
- Is there any difference in occurence of side effect in elderly between the use of moisturizers containing low molecular weight hyaluronic acid, high molecular weight hyaluronic acid, and vehicle?
- Conditions
- Xerosis Cutis
- Being tested
- Low molecular weight hyaluronic acid, High molecular weight hyaluronic acid, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight hyaluronic acidDrug
Also called LMWHA
Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle
High molecular weight hyaluronic acidDrug
Also called HMWHA
Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle
VehicleDrug
Also called Placebo
Vehicle ingredients including aqua, paraffinum liquidum, glycerin, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, arachidyl alcohol, squalane, behenyl alcohol, phenoxyethanol, arachidyl glucoside, allantoin, chlorphenesin, and disodium EDTA
| Study group | Role | What they receive |
|---|---|---|
| Topical 0,1% low molecular weight (7 kDa) hyaluronic acid | Experimental | Participants receive moisturizer containing 0,1% low molecular weight (7 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month Receives: Drug: Low molecular weight hyaluronic acid |
| Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid | Active comparator | Participants receive moisturizer containing 0,1% high molecular weight (1.800 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month Receives: Drug: High molecular weight hyaluronic acid |
| Vehicle | Placebo comparator | Participants receive vehicle on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin capacitance
Skin capacitance is measured by Corneometer CM825
Measured: 2 weeks and 4 weeks
Transepidermal water loss
Transepidermal water loss is measured by Tewameter TM300
Measured: 2 weeks and 4 weeks
Specified symptom sum score/scale, roughness, redness, crack (SRRC)
Evaluation of squama/scale, roughness, redness, and crack of the skin, with a value range of 0-16. Higher values mean worse outcome
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start26 Aug 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a split study, one participant receive three interventions in three area in the leg. The distribution of treatment groups is carried out randomly using the block randomization method.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parikesit Muhammad, Universitas Indonesia
- Investigators
- Parikesit Muhammad, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178367
- Sponsor's protocol ID
- 23061046
- Status last verified
- Apr 2024
- First submitted
- 10 Dec 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavicic T, Gauglitz GG, Lersch P, Schwach-Abdellaoui K, Malle B, Korting HC, Farwick M. Efficacy of cream-based novel formulations of hyaluronic acid of different molecular weights in anti-wrinkle treatment. J Drugs Dermatol. 2011 Sep;10(9):990-1000.
PubMed 22052267Ha NG, Lee SH, Lee EH, Chang M, Yoo J, Lee WJ. Safety and efficacy of a new hydrogel based on hyaluronic acid as cosmeceutical for xerosis. J Cosmet Dermatol. 2022 Dec;21(12):6840-6849. doi: 10.1111/jocd.15368. Epub 2022 Sep 20.
PubMed 36074117Muhammad P, Novianto E, Setyorini M, Legiawati L, Yusharyahya SN, Menaldi SL, Budianti WK. Effectiveness of topical hyaluronic acid of different molecular weights in xerosis cutis treatment in elderly: a double-blind, randomized controlled trial. Arch Dermatol Res. 2024 Jun 3;316(6):329. doi: 10.1007/s00403-024-03003-2.
PubMed 38829483
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Comparison Between Moisturizers Containing Low Molecular Weight Hyaluronic Acid, High Molecular Weight Hyaluronic Acid, and Vehicle on Skin Hydration in the Elderly With Xerotic Skin
- ClinicalTrials.gov ID
- NCT06178367
- Acronym / sponsor ID
- 23061046
- Conditions
- Xerosis Cutis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Dec 2023 (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 goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa) hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of xerotic skin in elderly
Detailed description
This clinical trial is conducted to compare the effectiveness and safety between moisturizers containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic acid, and its vehicle on skin hydration of elderly with xerotic skin. It is designed to answer following questions:
- Is the skin capacitance in the elderly after using moisturizers containing low molecular weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle?
- Is the transepidermal water loss in the elderly after using moisturizers containing high molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and vehicle?
- Is the dry skin score (SRRC) in the elderly after using moisturizers containing low molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and vehicle?
- Is there any difference in occurence of side effect in elderly between the use of moisturizers containing low molecular weight hyaluronic acid, high molecular weight hyaluronic acid, and vehicle?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a split study, one participant receive three interventions in three area in the leg. The distribution of treatment groups is carried out randomly using the block randomization method.
| Arm | Type | Receives |
|---|---|---|
| Topical 0,1% low molecular weight (7 kDa) hyaluronic acid | Experimental | Drug: Low molecular weight hyaluronic acidParticipants receive moisturizer containing 0,1% low molecular weight (7 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month |
| Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid | Active comparator | Drug: High molecular weight hyaluronic acidParticipants receive moisturizer containing 0,1% high molecular weight (1.800 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month |
| Vehicle | Placebo comparator | Drug: VehicleParticipants receive vehicle on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female or male diagnosed with xerotic skin
- 60-80 years old
- Willing to participate in clinical trial and sign informed consent
Key exclusion criteria (3 listed)
- History of hypersensitivity to moisturizer
- Dermatitis or any dermatosis on intervention area in the leg
- Score of erythema and crack more than 2, based on SRRC scoring
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 |
|---|---|---|
| Low molecular weight hyaluronic acidAlso: LMWHATopical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle | Drug | Topical 0,1% low molecular weight (7 kDa) hyaluronic acid |
| High molecular weight hyaluronic acidAlso: HMWHATopical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle | Drug | Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid |
| VehicleAlso: PlaceboVehicle ingredients including aqua, paraffinum liquidum, glycerin, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, arachidyl alcohol, squalane, behenyl alcohol, phenoxyethanol, arachidyl glucoside, allantoin, chlorphenesin, and disodium EDTA | Drug | Vehicle |
Primary outcome
Skin capacitance
Time frame: 2 weeks and 4 weeks
Skin capacitance is measured by Corneometer CM825
Transepidermal water loss
Time frame: 2 weeks and 4 weeks
Transepidermal water loss is measured by Tewameter TM300
Specified symptom sum score/scale, roughness, redness, crack (SRRC)
Time frame: 2 weeks and 4 weeks
Evaluation of squama/scale, roughness, redness, and crack of the skin, with a value range of 0-16. Higher values mean worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Results publication: PubMed 22052267Pavicic T, Gauglitz GG, Lersch P, Schwach-Abdellaoui K, Malle B, Korting HC, Farwick M. Efficacy of cream-based novel formulations of hyaluronic acid of different molecular weights in anti-wrinkle treatment. J Drugs Dermatol. 2011 Sep;10(9):990-1000.
- Results publication: PubMed 36074117Ha NG, Lee SH, Lee EH, Chang M, Yoo J, Lee WJ. Safety and efficacy of a new hydrogel based on hyaluronic acid as cosmeceutical for xerosis. J Cosmet Dermatol. 2022 Dec;21(12):6840-6849. doi: 10.1111/jocd.15368. Epub 2022 Sep 20.
- Derived from this study: PubMed 38829483Muhammad P, Novianto E, Setyorini M, Legiawati L, Yusharyahya SN, Menaldi SL, Budianti WK. Effectiveness of topical hyaluronic acid of different molecular weights in xerosis cutis treatment in elderly: a double-blind, randomized controlled trial. Arch Dermatol Res. 2024 Jun 3;316(6):329. doi: 10.1007/s00403-024-03003-2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Parikesit Muhammad, MD principal investigator
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low molecular weight hyaluronic acid and High molecular weight hyaluronic acid in people with Xerosis Cutis, run by Universitas Indonesia 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin capacitance (time frame: 2 weeks and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178367, which also lists 3 linked publications.
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 30 Apr 2024.