A Trial to Examine the Efficacy of a Hand Serum and Glove Combination.

July 22, 2024 updated by: Habelo Beauty
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hand Serum Alone First
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).
Other: Hand Serum and Glove
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.
Experimental: Hand Serum with Glove First
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).
Other: Hand Serum and Glove
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Perception of Skin Health and Appearance Between Gloved and Non-Gloved Hand using Study-Specific Perception Questionnaire
Time Frame: Baseline and Week 8
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.
Baseline and Week 8
Expert Skin Grading of Skin Health and Appearance Between Gloved and Non-Gloved Hand
Time Frame: Baseline and Week 8
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.
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Habelo Beauty

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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