Recruiting

Almond Oil & Tretinoin

Sponsor:

Integrative Skin Science and Research

Code:

NCT06571721

Conditions

Collagen Degeneration

Wrinkle

Pigmentation

Elastic Skin

Sebum Deficiency

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Topical Product: Almond Oil

Topical Product: Almond oil augmented with 0.5% Vitamin E

Topical Product: 0.025% Tretinoin oil augmented with castor oil

Study Details

Brief summary:

Investigate the topical use of almond oil, almond oil augmented with 0.5% vitamin E, 0.025% tretinoin oil augmented with castor oil on the appearance of facial fine lines and wrinkles, pigmentation, hydration, trans-epidermal water loss, and sebum excretion rate.

Conditions

Collagen Degeneration

Wrinkle

Pigmentation

Elastic Skin

Sebum Deficiency

Study ID

NCT06571721

Start date

Jul 22, 2024

Status verified date

Aug, 2024

Completion date

Jul 22, 2025

Anticipated

Primary completion date

Jan 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Post-menopausal women of Fitzpatrick skin types 1, 2, and 3
  • Individuals with facial fine lines and wrinkles

Exclusion Criteria:

  • Individuals who are pregnant or breastfeeding
  • Prisoners
  • Adults unable to consent
  • Those with a nut allergy or tocopherol allergy
  • Current smokers, those that have smoked within the past year, and former smokers with greater than a 10-pack- year history of smoking
  • Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndromes)
  • Those who have undergone any cosmetic procedures to the face in the 3 months prior to enrollment in the opinion of the investigator. People that have undergone deeper chemical peels (TCA based peels) within 1 year prior to enrollment
  • Individuals who are unwilling to discontinue vitamin E containing supplements and food sources such as all nuts, sunflower seeds or sunflower oil during the washout and intervention
  • Individual who are unwilling to discontinue topical cosmetic products during the duration of the study or unwilling to undergo a 2-week washout of topicals that are known to modulate collagen and pigment:
  • Retinoids such as tretinoin, adapalene, retinol, except as provided by the study.
  • Antioxidant ingredients such as vitamin C or vitamin E.
  • Pigment reducing agents such as hydroquinone, azelaic acid, kojic acid, or a retinoid except for the retinol that is provided in this study.
  • Topicals that contain a nut oil or nut extract as part of their ingredient list.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Almond Oil

Almond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

experimental: Almond oil augmented with 0.5% Vitamin E

Almond oil augmented with 0.5% Vitamin E. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

experimental: 0.025% Tretinoin oil augmented with castor oil

0.025% Tretinoin oil augmented with castor oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

Interventions

Topical Product: Almond Oil

1-2 Drops of randomized topical product will be applied on entire face nightly.

Topical Product: Almond oil augmented with 0.5% Vitamin E

1-2 Drops of randomized topical product will be applied on entire face nightly.

Topical Product: 0.025% Tretinoin oil augmented with castor oil

1-2 Drops of randomized topical product will be applied on entire face nightly.

Primary outcome measure

  • Facial wrinkles [ Time Frame: 16 Weeks ]

Central Contacts and Locations

Central contacts

Nasima Afzal

915-750-2463nasima@integrativeskinresearch.com

Locations

Integrative Research Institute

Recruiting

Sacramento, California, United States, 95819

Contacts

Nasima Afzal

915-750-2463nasima@integrativeskinresearch.com

Sarah Adnan

9157502463sarah@integrativeskinresearch.com

Principal Investigator:

Raja Sivamani, MD

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Aug 28, 2024

Last verified

Aug, 2024

Keywords

  • Facial Wrinkles
  • Skin biophysical properties
  • Photoaging
  • Pigmentation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2024-08-28.