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Skin AgingNCT07510165

Effects of Stabilized Retinaldehyde on Aging Skin: A Split-Face Study

A study testing Stabilized retinaldehyde 0.1% and Stabilized retinaldehyde 0.05% in people with Skin Aging and Photoaging, run by Medical University of Silesia at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn if retinaldehyde cream improves the appearance of aging skin in women aged 30 to 60 years. Retinaldehyde is a form of vitamin A that the skin can convert into retinoic acid, which is known to help with skin aging. Read more about this study

Who is it for?
Ages 30 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Aging, Photoaging
What is being tested?
Stabilized retinaldehyde 0.1% and Stabilized retinaldehyde 0.05%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 sitePoland
Study dates
1 Feb 2023to 31 Jul 2023
Phase
Interventional
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 30 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 30-60 years
  • Presence of wrinkles, dark spots, acne, seborrhea
  • Decreased skin firmness

Who cannot join

  • Exacerbated active atopic dermatitis on the face
  • Pregnancy
  • Skin infections
  • Numerous erosions or excoriations on facial skin
  • No aesthetic medical treatments within the preceding 6 months
  • Administration of botulinum toxin within the preceding 3 months
  • Irritated, dry skin
  • Irritated or excessively dry skin

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Sosnowiec, Poland

    Sosnowiec, 41-205

Other trials in Poland

About this study

Official title: Multimodal Assessment of Structural and Spectral Changes in Aging Skin Induced by Topical Application of Stabilized Retinaldehyde at 0.1% and 0.05%: A 24-Week Split-Face Study

The goal of this clinical trial is to learn if retinaldehyde cream improves the appearance of aging skin in women aged 30 to 60 years. Retinaldehyde is a form of vitamin A that the skin can convert into retinoic acid, which is known to help with skin aging. The study tested two strengths of retinaldehyde cream: a stronger version with 0.1% retinaldehyde and a weaker version with 0.05% retinaldehyde.

The main questions the study aimed to answer were: whether retinaldehyde cream improves skin hydration and reduces oiliness, whether it improves skin firmness and elasticity, whether it reduces wrinkles and improves skin texture, whether it reduces uneven skin tone and pigmentation, and whether the stronger 0.1% cream works better than the weaker 0.05% cream.

Read more

Researchers compared the two cream strengths by applying them to opposite sides of the same face. The stronger 0.1% cream was applied to the left side and the weaker 0.05% cream was applied to the right side. This approach allowed researchers to compare the two strengths directly in the same person under the same conditions.

56 women with visible signs of aging skin took part in the study at the Medical University of Silesia in Poland. One participant left the study early due to skin irritation. The remaining 55 women completed all 24 weeks of the study.

Participants apply the creams in the evening, starting with twice a week for the first 2 weeks, then increasing to 3 times a week in week 3 and 4 times a week in week 4, based on skin tolerance, for 24 weeks total. They also used a provided skincare routine every day, which included a lipid face cream, a cleansing lotion, and a sunscreen with SPF 50 to protect their skin during the study.

Participants were assessed 3 times: before starting the creams, after 12 weeks of use, and after 24 weeks of use. At each visit, researchers measured skin hydration, oiliness, elasticity, firmness, wrinkle depth, skin density, skin color, and other skin properties using a range of specialized skin measurement tools. Neither the participants nor the researchers assessing outcomes knew which cream strength was applied to which side of the face.

Read the detailed description

This study investigated the effects of topically applied stabilized retinaldehyde (RAL) at two concentrations (0.1% and 0.05%) on aging skin in 56 women (55 completing the study) aged 30-60 years (mean age 44.25 ± 8.1 years) with visible signs of photoaging including fine lines, wrinkles, pigmentation disorders, seborrhea, and loss of skin firmness.

A 24-week, double-blind, split-face design was employed. The 0.1% RAL formulation was applied to the left side of the face and the 0.05% formulation to the right side. Application frequency started with twice weekly for the first 2 weeks, increasing to three times per week in week 3 and four times per week in week 4, based on skin tolerance. Both formulations contained stabilized retinaldehyde encapsulated in a cyclodextrin-glycosaminoglycan complex to enhance stability and provide controlled transdermal delivery. The tested products were commercially available formulations provided by the study collaborator. All participants followed a standardized background skincare regimen consisting of a lipid cream, cleansing lotion, and SPF 50 sunscreen throughout the study period.

Skin assessments were performed at baseline (T0), after 12 weeks (T1), and after 24 weeks (T2) using a multimodal diagnostic approach at the Department of Basic Biomedical Sciences, Faculty of Pharmaceutical Sciences, Medical University of Silesia.

Biophysical measurements included stratum corneum hydration (Corneometer CM 825), sebum excretion rate (Sebumeter SM 815), and melanin and erythema indices (Mexameter MX 18). Structural assessments were performed using high-frequency ultrasound (DUB SkinScanner, 50 MHz) to evaluate skin density and epidermal thickness, and the Cutometer MPA 580 to assess skin viscoelasticity and elasticity parameters (R2, R5, R7, Q1, Q2). Wrinkle depth and surface parameters were evaluated using Antera 3D imaging. Optical and imaging assessments included colorimetric analysis of L*, a*, and b* values (Antera 3D), hyperspectral imaging across 400-1000 nm spectral range (SPECIM IQ), and Gray Level Co-Occurrence Matrix (GLCM) texture analysis including contrast and homogeneity of standardized clinical photographs (Fotomedicus system).

The study aimed to determine whether stabilized RAL induces measurable structural, vascular, spectral, and optical changes in aging skin, and to compare the dose-dependent efficacy of 0.1% versus 0.05% concentrations across all measured parameters.

One participant withdrew from the study due to facial erythema and discomfort. No other serious adverse events were reported.

Being tested
Stabilized retinaldehyde 0.1%, Stabilized retinaldehyde 0.05%
Keywords
Retinaldehyde, Retinoid, Split-face study, Skin hydration, Hyperspectral imaging, GLCM texture analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stabilized retinaldehyde 0.1%Other

    Also called Retinal 0.1%

    Stabilized retinaldehyde 0.1% encapsulated in a cyclodextrin-glycosaminoglycan complex, formulated as a topical cosmetic cream, applied to the left side of the face. Application frequency started with twice weekly for the first 2 weeks, increasing to three times per week in week 3 and four times per week in week 4, based on skin tolerance, for a total of 24 weeks.

  • Stabilized retinaldehyde 0.05%Other

    Also called Retinal 0.05%

    Stabilized retinaldehyde 0.05% encapsulated in a cyclodextrin-glycosaminoglycan complex, formulated as a topical cosmetic cream, applied to the right side of the face. Application frequency started with twice weekly for the first 2 weeks, increasing to three times per week in week 3 and four times per week in week 4, based on skin tolerance, for a total of 24 weeks.

Study groups in NCT07510165
Study groupRoleWhat they receive
Retinaldehyde 0.1% (Left Side)ExperimentalStabilized retinaldehyde 0.1% formulation applied to the left side of the face for 24 weeks. Application frequency started with twice weekly for the first 2 weeks, increasing to three times per week in week 3 and four times per week in week 4, based on skin tolerance.
Receives: Other: Stabilized retinaldehyde 0.1%
Retinaldehyde 0.05% (Right Side)ExperimentalStabilized retinaldehyde 0.05% formulation applied to the right side of the face for 24 weeks. Application frequency started with twice weekly for the first 2 weeks, increasing to three times per week in week 3 and four times per week in week 4, based on skin tolerance.
Receives: Other: Stabilized retinaldehyde 0.05%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin Hydration

    Stratum corneum hydration measured using Corneometer CM 825 (Courage+Khazaka, Germany). Three consecutive measurements taken at predefined anatomical landmarks on both sides of the face.

    Measured: Baseline and 24 weeks

  2. Sebum Excretion Rate

    Sebum levels measured using Sebumeter SM 815 (Courage+Khazaka, Germany). Single measurement at each predefined anatomical site applied with constant pressure of 10 N for 30 seconds.

    Measured: Baseline and 24 weeks

  3. Melanin Index

    Melanin content measured using Mexameter MX 18 (Courage+Khazaka, Germany). Three consecutive measurements taken at predefined anatomical landmarks.

    Measured: Baseline and 24 weeks

  4. Erythema Index

    Erythema measured using Mexameter MX 18 (Courage+Khazaka, Germany). Three consecutive measurements taken at predefined anatomical landmarks.

    Measured: Baseline and 24 weeks

  5. Skin Density and Epidermal Thickness

    Assessed using high-frequency ultrasound DUB SkinScanner 50 MHz. Skin density measured using ROI function directly beneath epidermis. Epidermal thickness calculated in millimeters based on A-scan.

    Measured: Baseline and 24 weeks

  6. Skin Viscoelasticity and Elasticity

    Assessed using Cutometer MPA 580 (Courage+Khazaka, Germany) with 2 mm probe. Parameters R2, R5, R7, Q1, Q2 extracted from deformation curves.

    Measured: Baseline and 24 weeks

  7. Wrinkle Depth and Surface Parameters

    Assessed using Antera 3D imaging system (Miravex Limited, Ireland) with multi-directional illumination. ROIs of 20x20 mm at predefined anatomical landmarks.

    Measured: Baseline and 24 weeks

  8. Colorimetric Parameters

    L*, a*, b* values measured using Antera 3D imaging system (Miravex Limited, Ireland). Data extracted from standardized ROIs of 20x20 mm.

    Measured: Baseline and 24 weeks

  9. Skin Texture - GLCM Analysis

    Contrast and homogeneity assessed using Gray Level Co-Occurrence Matrix (GLCM) analysis of standardized clinical photographs taken with Fotomedicus system (Elfo, Poland). ROIs of 200x200 pixels extracted from central cheek coordinates.

    Measured: Baseline and 24 weeks

  10. Hyperspectral Imaging

    Reflectance and hemoglobin variability assessed using SPECIM IQ hyperspectral camera (Specim, Finland), spectral range 400-1000 nm, spectral resolution 5 nm. ROIs of 100x100 pixels from predefined cheek coordinates.

    Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start1 Feb 2023
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
A split-face design was used, in which each participant received both concentrations simultaneously - 0.1% RAL on the left side of the face and 0.05% RAL on the right side - allowing direct intra-individual comparison of dose-dependent effects over 24 weeks.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510165
Sponsor's protocol ID
PCN/0022/KB1/11/I/20
Status last verified
Mar 2026
First submitted
26 Mar 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in publications will be shared upon reasonable request. This includes data necessary to reproduce the findings presented in the articles. Data will be available after publication, subject to institutional policies, ethical approval, and applicable data protection regulations. No directly identifiable data will be shared. Supporting documents such as the study protocol and statistical analysis plan may also be made available upon request.

Publications

  • Deda A, Odrzywolek W, Lebiedowska A, Banys A, Bozek M, Kuca D, Wisniewska N, Wcislo-Dziadecka D, Wilczynski S. Comparative Evaluation of Topical Stabilized Retinaldehyde 0.1% vs. 0.05% on Skin Biophysical and Biomechanical Parameters. Skin Res Technol. 2026 Feb;32(2):e70326. doi: 10.1111/srt.70326.

    PubMed 41729119

Questions about this trial

What is this clinical trial studying?

A study testing Stabilized retinaldehyde 0.1% and Stabilized retinaldehyde 0.05% in people with Skin Aging and Photoaging, run by Medical University of Silesia at 1 site in Poland.

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 8 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 3 Apr 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 Poland. 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. 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?

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 Hydration (time frame: Baseline and 24 weeks). The study lists 10 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 NCT07510165, which also lists 1 linked publication.

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 3 Apr 2026.

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