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Completed

NCT Number: NCT05778760

Prospective Study of Topical Adapinoid Versus Topical Retinol

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.

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Key information

Conditions

Wrinkle

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Retinol

Other

Topical retinol (0.5%) applied to the face

Adapinoid

Other

Topical Adapinoid (0.5%) applied to the face

Primary outcomes

  1. Facial fine lines and wrinkles

    Time frame: 12 weeks

    Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)

Secondary outcomes

  1. Facial fine lines and wrinkles

    Time frame: 4 weeks

    Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)

  2. Facial fine lines and wrinkles

    Time frame: 8 weeks

    Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)

  3. Skin redness

    Time frame: 4 weeks

    Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)

  4. Skin redness

    Time frame: 8 weeks

    Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)

  5. Skin redness

    Time frame: 12 weeks

    Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)

  6. Facial skin pigment evenness

    Time frame: 4 weeks

    Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)

  7. Facial skin pigment evenness

    Time frame: 8 weeks

    Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)

  8. Facial skin pigment evenness

    Time frame: 12 weeks

    Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)

  9. Self-perception of skin health and appearance

    Time frame: 4 weeks

    Survey-based self-assessment of aspects of skin health and appearance

  10. Self-perception of skin health and appearance

    Time frame: 8 weeks

    Survey-based self-assessment of aspects of skin health and appearance

  11. Self-perception of skin health and appearance

    Time frame: 12 weeks

    Survey-based self-assessment of aspects of skin health and appearance

  12. Tolerability of product

    Time frame: 4 weeks

    Questionnaire based self-assessment about the tolerability of the topical skin product

  13. Tolerability of product

    Time frame: 8 weeks

    Questionnaire based self-assessment about the tolerability of the topical skin product

  14. Tolerability of product

    Time frame: 12 weeks

    Questionnaire based self-assessment about the tolerability of the topical skin product

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Actera (Sponsor)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
Jun 18, 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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