WrinkleNCT05778760
Prospective Study of Topical Adapinoid Versus Topical Retinol
A study testing Retinol and Adapinoid in people with Wrinkle, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Retinol and Adapinoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Sep 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 35 years old and 65 years old
Who cannot join
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
- Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
Official title: Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Adapinoid Versus Topical Retinol
This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient.
Read the detailed description
We want to assess the effect of applying vitamin A-derived ingredients on facial skin health, appearance, and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate.
In this study, participants will be randomized to either receiving a retinol product, or an Adapinoid product and they will be assessed at three follow up visits at week 4, week 8, and week 12.
- Conditions
- Wrinkle
- Being tested
- Retinol, Adapinoid
- Keywords
- anti-aging, skin care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetinolOther
Topical retinol (0.5%) applied to the face
AdapinoidOther
Topical Adapinoid (0.5%) applied to the face
| Study group | Role | What they receive |
|---|---|---|
| Retinol | Active comparator | Product will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face. Receives: Other: Retinol |
| Adapinoid | Experimental | Product will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face. Receives: Other: Adapinoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial fine lines and wrinkles
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Measured: 12 weeks
Secondary outcomes (14)
Facial fine lines and wrinkles
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Measured: 4 weeks
Facial fine lines and wrinkles
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Skin redness
Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)
Measured: 4 weeks
Skin redness
Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Skin redness
Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)
Measured: 12 weeks
Facial skin pigment evenness
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
Measured: 4 weeks
Facial skin pigment evenness
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Facial skin pigment evenness
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
Measured: 12 weeks
Self-perception of skin health and appearance
Survey-based self-assessment of aspects of skin health and appearance
Measured: 4 weeks
Self-perception of skin health and appearance
Survey-based self-assessment of aspects of skin health and appearance
Measured: 8 weeks
Self-perception of skin health and appearance
Survey-based self-assessment of aspects of skin health and appearance
Measured: 12 weeks
Tolerability of product
Questionnaire based self-assessment about the tolerability of the topical skin product
Measured: 4 weeks
Tolerability of product
Questionnaire based self-assessment about the tolerability of the topical skin product
Measured: 8 weeks
Tolerability of product
Questionnaire based self-assessment about the tolerability of the topical skin product
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 May 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Actera (Sponsor)
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778760
- Sponsor's protocol ID
- ADAP_RET
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen N, Afzal N, Min M, Ahmad N, Afzal L, Burney W, Chambers CJ, Sivamani RK. A prospective, double-blinded, randomized head-to-head clinical trial of topical adapinoid (oleyl adapalenate) versus retinol. Skin Health Dis. 2024 Nov 4;4(6):e469. doi: 10.1002/ski2.469. eCollection 2024 Dec.
PubMed 39624736
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Adapinoid Versus Topical Retinol
- ClinicalTrials.gov ID
- NCT05778760
- Acronym / sponsor ID
- ADAP_RET
- Conditions
- Wrinkle
- Keywords
- anti-aging, skin care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Actera (Sponsor)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 21 Mar 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.
This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient.
Detailed description
We want to assess the effect of applying vitamin A-derived ingredients on facial skin health, appearance, and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate.
In this study, participants will be randomized to either receiving a retinol product, or an Adapinoid product and they will be assessed at three follow up visits at week 4, week 8, and week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retinol | Active comparator | Other: RetinolProduct will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face. |
| Adapinoid | Experimental | Other: AdapinoidProduct will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women between the ages of 35 years old and 65 years old
Key exclusion criteria (7 listed)
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
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 |
|---|---|---|
| RetinolTopical retinol (0.5%) applied to the face | Other | Retinol |
| AdapinoidTopical Adapinoid (0.5%) applied to the face | Other | Adapinoid |
Primary outcome
Facial fine lines and wrinkles
Time frame: 12 weeks
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
14 secondary outcomes
Facial fine lines and wrinkles
Time frame: 4 weeks
Facial fine lines and wrinkles
Time frame: 8 weeks
Skin redness
Time frame: 4 weeks
Skin redness
Time frame: 8 weeks
Skin redness
Time frame: 12 weeks
Facial skin pigment evenness
Time frame: 4 weeks
Facial skin pigment evenness
Time frame: 8 weeks
Facial skin pigment evenness
Time frame: 12 weeks
Self-perception of skin health and appearance
Time frame: 4 weeks
Self-perception of skin health and appearance
Time frame: 8 weeks
Self-perception of skin health and appearance
Time frame: 12 weeks
Tolerability of product
Time frame: 4 weeks
Tolerability of product
Time frame: 8 weeks
Tolerability of product
Time frame: 12 weeks
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 18 Jun 2024.
- Derived from this study: PubMed 39624736Nguyen N, Afzal N, Min M, Ahmad N, Afzal L, Burney W, Chambers CJ, Sivamani RK. A prospective, double-blinded, randomized head-to-head clinical trial of topical adapinoid (oleyl adapalenate) versus retinol. Skin Health Dis. 2024 Nov 4;4(6):e469. doi: 10.1002/ski2.469. eCollection 2024 Dec.
- 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.
Raja Sivamani, MD principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinol and Adapinoid in people with Wrinkle, run by Integrative Skin Science and Research at 1 site in United States.
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 1 inclusion and 7 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 18 Jun 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 United States. 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?
Facial fine lines and wrinkles (time frame: 12 weeks). 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 NCT05778760, 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 18 Jun 2024.