Skin HealthNCT06521177
A Trial to Examine the Efficacy of a Hand Serum and Glove Combination.
A study testing Hand Serum and Glove in people with Skin Health and Dermatology, run by Habelo Beauty at 1 site in United States.
Trial summary
This is a virtual, 8-week, interventional crossover trial with 33 female participants aged 35 and older. The study aims to evaluate the efficacy of Habelo Beauty's Activating Hand Serum and Glove combination in improving hand skin health and appearance. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health, Dermatology, Skin Care
- What is being tested?
- Hand Serum and Glove
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 7 Jul 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, 35+ years old.
- Concerns about signs of skin aging on hands.
- Willing to discontinue other hand lotions or serums.
- Generally healthy, able to follow the study protocol.
- Access to someone to take hand photos at Baseline and Week 8.
- Consistent use of SPF for the duration of the study.
Who cannot join
- Chronic skin conditions on hands.
- History of skin cancer or pre-cancerous lesions on hands.
- Pregnant, breastfeeding, or trying to conceive.
- Inability to follow study protocol.
- Current significant medical procedures planned within the study duration.
- Severe allergies or reactions to product ingredients.
- Current or planned hand casting or splinting.
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual, 8-week, interventional crossover trial with 33 female participants aged 35 and older. The study aims to evaluate the efficacy of Habelo Beauty's Activating Hand Serum and Glove combination in improving hand skin health and appearance. During Weeks 1-6, participants will apply the Hand Serum to both hands daily. In Weeks 7-8, they will continue applying the Hand Serum and also wear a glove on one hand. Assessments will be conducted via questionnaires and photos at multiple time points to evaluate primary and secondary endpoints related to skin health parameters.
- Conditions
- Skin Health, Dermatology, Skin Care
- Being tested
- Hand Serum and Glove
- Keywords
- Cosmetic Study, Anti-Aging, Skin Appearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Serum and GloveOther
Participants will apply the Hand Serum to both hands daily for 8 weeks. During Weeks 7-8, participants will also wear a glove on one hand. The intervention aims to improve skin health and appearance on the hands, assessed through questionnaires and expert skin grading.
| Study group | Role | What they receive |
|---|---|---|
| Hand Serum Alone First | Experimental | Participants will apply Hand Serum alone for the first period (6 weeks), followed by applying Hand Serum with Glove in the second period (6 weeks). Receives: Other: Hand Serum and Glove |
| Hand Serum with Glove First | Experimental | Participants will apply Hand Serum with Glove for the first period (6 weeks), followed by applying Hand Serum alone in the second period (6 weeks). Receives: Other: Hand Serum and Glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Overall Skin Health and Hydration using Expert Skin Grading
Assessment of overall skin health and hydration parameters, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Measured: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Improvement in Skin Radiance and Plumpness using Expert Skin Grading
Assessment of skin radiance and plumpness parameters, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Measured: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Reduction in Dark Spots and Redness using Expert Skin Grading
Assessment of dark spots and redness, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Measured: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Reduction in Fine Lines and Crepe Appearance using Expert Skin Grading
Assessment of fine lines and 'crepe' appearance, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Measured: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes (2)
Participant Perception of Skin Health and Appearance Between Gloved and Non-Gloved Hand using Study-Specific Perception Questionnaire
Comparison of participant perception of skin health and appearance changes between the hand that had the Hand Serum only applied and the hand that had the Hand Serum plus the Glove at Endline. This will be assessed via a study-specific perception questionnaire at Baseline and Endline.
Measured: Baseline and Week 8
Expert Skin Grading of Skin Health and Appearance Between Gloved and Non-Gloved Hand
Comparison of expert skin grading of skin health and appearance changes between the hand that had the Hand Serum only applied and the hand that had the Hand Serum plus the Glove at Endline. This will be conducted at Baseline and Endline.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start21 Mar 2024
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- A crossover trial where participants are randomized to receive either Hand Serum alone or Hand Serum with Glove in the first period, followed by the alternate intervention in the second period.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Habelo Beauty
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521177
- Sponsor's protocol ID
- 20418
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Examine the Efficacy of a Hand Serum and Glove Combination.
- ClinicalTrials.gov ID
- NCT06521177
- Acronym / sponsor ID
- 20418
- Conditions
- Skin Health, Dermatology, Skin Care
- Keywords
- Cosmetic Study, Anti-Aging, Skin Appearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Habelo BeautyIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 25 Jul 2024 (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 is a virtual, 8-week, interventional crossover trial with 33 female participants aged 35 and older. The study aims to evaluate the efficacy of Habelo Beauty's Activating Hand Serum and Glove combination in improving hand skin health and appearance. During Weeks 1-6, participants will apply the Hand Serum to both hands daily. In Weeks 7-8, they will continue applying the Hand Serum and also wear a glove on one hand. Assessments will be conducted via questionnaires and photos at multiple time points to evaluate primary and secondary endpoints related to skin health parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A crossover trial where participants are randomized to receive either Hand Serum alone or Hand Serum with Glove in the first period, followed by the alternate intervention in the second period.
| Arm | Type | Receives |
|---|---|---|
| Hand Serum Alone First | Experimental | Other: Hand Serum and GloveParticipants will apply Hand Serum alone for the first period (6 weeks), followed by applying Hand Serum with Glove in the second period (6 weeks). |
| Hand Serum with Glove First | Experimental | Other: Hand Serum and GloveParticipants will apply Hand Serum with Glove for the first period (6 weeks), followed by applying Hand Serum alone in the second period (6 weeks). |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, 35+ years old.
- Concerns about signs of skin aging on hands.
- Willing to discontinue other hand lotions or serums.
- Generally healthy, able to follow the study protocol.
- Access to someone to take hand photos at Baseline and Week 8.
Key exclusion criteria (7 listed)
- Chronic skin conditions on hands.
- History of skin cancer or pre-cancerous lesions on hands.
- Pregnant, breastfeeding, or trying to conceive.
- Inability to follow study protocol.
- Current significant medical procedures planned within the study duration.
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 |
|---|---|---|
| Hand Serum and GloveParticipants will apply the Hand Serum to both hands daily for 8 weeks. During Weeks 7-8, participants will also wear a glove on one hand. The intervention aims to improve skin health and appearance on the hands, assessed through questionnaires and expert skin grading. | Other | Hand Serum Alone First, Hand Serum with Glove First |
Primary outcome
Improvement in Overall Skin Health and Hydration using Expert Skin Grading
Time frame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Assessment of overall skin health and hydration parameters, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Improvement in Skin Radiance and Plumpness using Expert Skin Grading
Time frame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Assessment of skin radiance and plumpness parameters, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Reduction in Dark Spots and Redness using Expert Skin Grading
Time frame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Assessment of dark spots and redness, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
Reduction in Fine Lines and Crepe Appearance using Expert Skin Grading
Time frame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Assessment of fine lines and 'crepe' appearance, measured through expert skin grading and study-specific questionnaires. These assessments will be conducted at Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8.
2 secondary outcomes
Participant Perception of Skin Health and Appearance Between Gloved and Non-Gloved Hand using Study-Specific Perception Questionnaire
Time frame: Baseline and Week 8
Expert Skin Grading of Skin Health and Appearance Between Gloved and Non-Gloved Hand
Time frame: Baseline and Week 8
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 25 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Serum and Glove in people with Skin Health and Dermatology, run by Habelo Beauty 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 6 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 25 Jul 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?
Improvement in Overall Skin Health and Hydration using Expert Skin Grading (time frame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8). The study lists 4 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 25 Jul 2024.