The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles

NCT06571721 | Recruiting DMC

• 1 other identifier: IRI24_01_AlmondOil
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Facial Wrinkles; Skin biophysical properties; Photoaging; Pigmentation

Outcome Measures

Primary Outcomes (1)

• Facial wrinkles

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

  16 Weeks

Secondary Outcomes (6)

• Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro)

  16 Weeks

• Pigment intensity measured through SkinColorCatch.

  16 Weeks

• Changes in skin hydration

  16 Weeks

• Sebum excretion rate

  16 Weeks

• Tolerability Assessment Questionnaire

  16 Weeks

Study Arms (3)

Almond Oil

EXPERIMENTAL

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

Other: Topical Product: Almond Oil

Almond oil augmented with 0.5% Vitamin E

EXPERIMENTAL

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

Other: Topical Product: Almond oil augmented with 0.5% Vitamin E

0.025% Tretinoin oil augmented with castor oil

EXPERIMENTAL

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

Other: Topical Product: 0.025% Tretinoin oil augmented with castor oil

Interventions

Topical Product: Almond Oil OTHER

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

Almond Oil

Topical Product: Almond oil augmented with 0.5% Vitamin E OTHER

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

Almond oil augmented with 0.5% Vitamin E

Topical Product: 0.025% Tretinoin oil augmented with castor oil OTHER

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

0.025% Tretinoin oil augmented with castor oil

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead

Study Sites (1)

Integrative Research Institute

Sacramento, California, 95819, United States

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Interventions

Vitamin E; Pharmaceutical Preparations; Castor Oil

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Central Study Contacts

Nasima Afzal

CONTACT

915-750-2463; nasima@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: July 22, 2024
• Primary Completion: January 22, 2025
• Study Completion: July 22, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)