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

NCT06521177 | Completed

• 1 other identifier: 20418
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Cosmetic Study; Anti-Aging; Skin Appearance

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Baseline and Week 8

• Expert Skin Grading of Skin Health and Appearance Between Gloved and Non-Gloved Hand

  Baseline and Week 8

Study Arms (2)

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).

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).

Other: Hand Serum and Glove

Interventions

Hand Serum and Glove OTHER

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.

Hand Serum Alone First; Hand Serum with Glove First

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Habelo Beauty: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Interventions

Gloves, Protective

Intervention Hierarchy (Ancestors)

Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 25, 2024
• Study Start: March 21, 2024
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)