Clinical trial NCT06521177: A Trial to Examine the Efficacy of a Hand Serum and Glove Combination.
Official title: A Trial to Examine the Efficacy of a Hand Serum and Glove Combination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Health
Dermatology
Skin Care
Keywords: Cosmetic Study
Anti-Aging
Skin Appearance
Lead sponsor: Habelo Beauty
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-25
Enrollment: 33
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Overall Skin Health and Hydration using Expert Skin Grading
timeFrame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
measure: Improvement in Skin Radiance and Plumpness using Expert Skin Grading
timeFrame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
measure: Reduction in Dark Spots and Redness using Expert Skin Grading
timeFrame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
measure: Reduction in Fine Lines and Crepe Appearance using Expert Skin Grading
timeFrame: Baseline, Day 1, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes:
measure: Participant Perception of Skin Health and Appearance Between Gloved and Non-Gloved Hand using Study-Specific Perception Questionnaire
timeFrame: Baseline and Week 8
measure: Expert Skin Grading of Skin Health and Appearance Between Gloved and Non-Gloved Hand
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: