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Completed

NCT Number: NCT06521177

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

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.

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Key information

Conditions

Skin Health Dermatology Skin Care

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Habelo Beauty

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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