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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • 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

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
Intervention / Treatment
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

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

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

Habelo Beauty

Collaborators

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)

March 21, 2024

Primary Completion (Actual)

July 7, 2024

Study Completion (Actual)

July 7, 2024

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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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