A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming

NCT04065035 | Completed

• 1 other identifier: C18-D134
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, split-body, double-blind, randomized, controlled clinical trial was conducted to assess the efficacy and tolerance of a topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.

Conditions

Photodamaged Skin; Skin Care

Keywords

Body; moisturizer; Firming

Outcome Measures

Primary Outcomes (17)

• Change from Baseline in Skin Crepiness Score

  Investigator assessed the participants' skin crepiness using a 10-point scale where none 0 = skin appears smooth with no crinkling to severe 9 = prominent, extensive crinkly texture at baseline, week 4, 8, and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Skin Elasticity Score

  Investigator assessed the participants' skin elasticity using a 10-point scale where none 0 = skin feels toned, dense and resilient to severe 9 = skin feels pliable, thin and nonresilient at baseline, week 8 and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Skin Firmness Score

  Investigator assessed the participants' skin firmness using a 10-point scale where none 0 = skin appears very firm and feels thick to severe 9 = loose-appearing skin with poor stretch properties at baseline, week 8 and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Skin Sagging Score

  Investigator assessed the participants' skin sagging using a 10-point scale where none 0 = no sagging, upper arm shows tight, lifted appearance to severe 9 = upper arm shows extreme sagging appearance at baseline, week 8 and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Skin Roughness (Visual) Score

  Investigator assessed the participants' skin roughness (visual) using a 10-point scale where none 0 = smooth skin appearance, no roughness to severe 9 = pronounced reduction in skin smoothness appearance at baseline, week 4. 8, and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Skin Roughness (Tactile) Score

  Investigator assessed the participants' skin roughness (tactile) using a 10-point scale where none 0 = no palpable skin roughness, drag or surface bumps to severe 9 = significantly palpable skin roughness, drag, and surface bumps at baseline, week 4, 8 and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Overall Photodamage Score

  Investigator assessed the participants' overall photodamage using a 10-point scale where none 0 = none or minimal visual evidence of photodamaged skin to severe 9 = severe photodamaged skin at baseline, week 8 and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Evenness of Skin Tone Score

  Investigator assessed the participants' evenness of skin tone using a 10-point scale where none 0 = even skin color, no observable hyperpigmentation to severe 9 = significant detectable hyperpigmentation appearance at baseline, week 8 and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Evenness of Skin Redness Score

  Investigator assessed the participants' evenness of skin redness using a 10-point scale where none 0 = even skin tone to severe 9 = pronounced areas of redness at baseline, week 4, 8, and 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Objective Erythema Parameters

  Investigator assessed the participants' signs of erythema using a 4-point scale where none 0 = no erythema to severe 4 = marked redness at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Objective Edema Parameters

  Investigator assessed the participants' signs of edema using a 4-point scale where none 0 = no edema or swelling to severe 4 = marked edema at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Objective Dryness Parameters

  Investigator assessed the participants' signs of dryness using a 4-point scale where none 0 = no dryness to severe 4 = marked dryness at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Objective Peeling Parameters

  Investigator assessed the participants' signs of peeling using a 4-point scale where none 0 = no peeling to severe 4 = marked peeling at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Subjective Burning Parameters

  Participants assessed signs of burning using a 4-point scale where none 0 = no burning to severe 4 = hot burning sensation at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Subjective Stinging Parameters

  Participants assessed signs of stinging using a 4-point scale where none 0 = no stinging to severe 4 = marked stinging sensation at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Subjective Itching Parameters

  Participants assessed signs of itching using a 4-point scale where none 0 = no itching to severe 4 = marked itching sensation at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

• Change from Baseline in Subjective Tingling Parameters

  Participants assessed signs of tingling using a 4-point scale where none 0 = no tingling to severe 4 = marked tingling sensation at baseline and week 12. A decrease in score indicates improvement.

  12 weeks

Study Arms (2)

Topical Firming Body Moisturizer

ACTIVE COMPARATOR

Oil-in-water emulsion base containing emollients, botanical extracts, peptides, antioxidants, prebiotics, and modified theophylline ingredients.

Other: Topical Body Firming Moisturizer; Other: Body Cleanser; Other: Sunscreen

Placebo Moisturizer

PLACEBO COMPARATOR

Oil-in-water emulsion base containing emollients.

Other: Body Cleanser; Other: Sunscreen; Other: Placebo Moisturizer

Interventions

Topical Body Firming Moisturizer OTHER

Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation

Topical Firming Body Moisturizer

Body Cleanser OTHER

Body cleanser to be used by study participants

Also known as: Dove Sensitive Skin Nourishing Body Wash

Placebo Moisturizer; Topical Firming Body Moisturizer

Sunscreen OTHER

Sunscreen to be applied after application of moisturizer

Also known as: Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55

Placebo Moisturizer; Topical Firming Body Moisturizer

Placebo Moisturizer OTHER

Placebo moisturizer is the vehicle control of the topical body firming moisturizer

Placebo Moisturizer

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 40 and 60 years
• Mild to moderate skin crepiness upper arm region
• Mild to moderate sagging skin upper arm region
• Mild to moderate overall photodamage upper arm region
• Willing to maintain their body weight within +/- 6.5 pounds

You may not qualify if:

• Diagnosed with known allergies to skin care products
• Who have had massive weight loss
• Who have undergone liposuction and/or weight loss surgery in the last 5 years.
• Who are nursing
• Who are pregnant
• History of skin cancer within the past 5 years.
• Having a health condition
• Having a history of immunosuppression/immune deficiency disorders
• Currently using oral or systemic immunosuppressive medications and biologics
• Currently using or having regularly used corticosteroids
• Having a disease such as asthma
• Having started a long-term medication within the last 2 months.
• Who started hormone replacement therapies (HRT)
• Having had brachioplasty (upper arm lift);
• Having liposuction

Sponsors & Collaborators

• Revision Skincare: lead
• Stephens & Associates, Inc.: collaborator

Study Sites (1)

Stephens and Associates

Richardson, Texas, 75081, United States

Location

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Lily Jiang, PhD

  Thomas J. Stephens & Associates, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Prior to the start of the study, Stephens will generate 2 randomization lists (1 for biopsy subjects and 1 for non-biopsy subjects) to establish treatment assignment to 1 arm (left or right) with the other arm untreated (receiving a placebo). Each list will first be created by concatenating blocks of size of 4 subjects, 2 with left arm treated/right arm untreated and 2 with right arm treated/left arm untreated. The lists will then be randomized by variables from 2 independent uniform distributions: 1 to randomize subjects within block and 1 to randomize blocks. After the randomization lists are created, treatment arm will be assigned to each subject number accordingly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split Body, randomized, and placebo controlled

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 22, 2019
• Study Start: December 13, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 17, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

US (1)