Prospective Study of Topical Adapinoid Versus Topical Retinol

Wrinkle Clinical Trial

Official title:

Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Adapinoid Versus Topical Retinol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778760
• Other study ID #: ADAP_RET
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2024
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient.

Description:

We want to assess the effect of applying vitamin A-derived ingredients on facial skin health, appearance, and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate.

In this study, participants will be randomized to either receiving a retinol product, or an Adapinoid product and they will be assessed at three follow up visits at week 4, week 8, and week 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women between the ages of 35 years old and 65 years old

Exclusion Criteria:

• Individuals who are pregnant or breastfeeding.

• Prisoners.

• Adults unable to consent.

• Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.

• Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.

• Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.

• Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Related Conditions & MeSH terms

• Wrinkle

Intervention

Other:
• Retinol
Topical retinol (0.5%) applied to the face
• Adapinoid
Topical Adapinoid (0.5%) applied to the face

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Actera (Sponsor)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial fine lines and wrinkles	Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)	12 weeks
Secondary	Facial fine lines and wrinkles	Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Secondary	Facial fine lines and wrinkles	Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)	8 weeks
Secondary	Skin redness	Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Secondary	Skin redness	Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)	8 weeks
Secondary	Skin redness	Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)	12 weeks
Secondary	Facial skin pigment evenness	Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Secondary	Facial skin pigment evenness	Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)	8 weeks
Secondary	Facial skin pigment evenness	Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)	12 weeks
Secondary	Self-perception of skin health and appearance	Survey-based self-assessment of aspects of skin health and appearance	4 weeks
Secondary	Self-perception of skin health and appearance	Survey-based self-assessment of aspects of skin health and appearance	8 weeks
Secondary	Self-perception of skin health and appearance	Survey-based self-assessment of aspects of skin health and appearance	12 weeks
Secondary	Tolerability of product	Questionnaire based self-assessment about the tolerability of the topical skin product	4 weeks
Secondary	Tolerability of product	Questionnaire based self-assessment about the tolerability of the topical skin product	8 weeks
Secondary	Tolerability of product	Questionnaire based self-assessment about the tolerability of the topical skin product	12 weeks