NCT05039476

Brief Summary

Chemist Confessions has developed a retinol cream with the aim to improve the appearance of early signs of aging, such as fine lines, dark spots, hyperpigmentation, and crow's feet. In this phase, Chemist Confessions plans to collect self-reported outcomes and photographic images to understand the assessment of the efficacy of treatment from the participant's perspective, and if participants see an improvement in their fine lines, wrinkles, dark spots, hyperpigmentation, and crow's feet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

September 1, 2021

Last Update Submit

February 6, 2023

Conditions

WrinkleAging

Outcome Measures

Primary Outcomes (1)

  • Improvement of skin appearance of early signs of aging

    The primary objective of this study is to understand if Chemist Confessions retinol cream is capable of improving the appearance of early signs of aging such as fine lines, dark spots, wrinkles, hyperpigmentation and crow's feet, and to determine if it helps to improve the overall skin health by promoting hydrated, brightened skin for study participants. To evaluate the improvement of this outcome measure VISIA imaging will be used.

    12 weeks

Study Arms (2)

Retinol face cream

ACTIVE COMPARATOR

Retinol face cream on one half of the participant's face

Dietary Supplement: Retinol face cream

Placebo face cream

PLACEBO COMPARATOR

Placebo face cream on one half of the participant's face

Dietary Supplement: Placebo face cream

Interventions

Retinol face creamDIETARY_SUPPLEMENT

Retinol face cream

Retinol face cream
Placebo face creamDIETARY_SUPPLEMENT

Placebo face cream

Placebo face cream

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale between 30-50 years old
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female between 30-50 years old
  • Must be in good general health
  • Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
  • May experience hyperpigmentation, dark spots and dark circles
  • Must maintain the following skincare routine containing: cleansing, allowed moisturizer and study specific sunscreen
  • Must use study provided sunscreen daily
  • Must discontinue the use of other retinoids 4 weeks before the study start date
  • Must have some general knowledge of retinoid use
  • Must be willing to comply with the requirements of the protocol
  • Must be able to communicate in English
  • Must be able to tell left from right
  • Must willing to add the retinoid cream to their skincare routine
  • Must provide written informed consent form (ICF)
  • Is willing and able to share feedback and take skin pictures via the used technology portal
  • Must be willing to refrain from using products with chemical exfoliants glycolic acid and lactic acid during the duration of the study

You may not qualify if:

  • Unwilling to provide consent
  • Unwilling to add the retinoid cream to their normal skincare routine
  • Unwilling to follow the routine of the protocol
  • Uses moisturizers that include chemical exfoliating ingredients such as glycolic acid, lactic acid or salicylic acid
  • Use of other oral retinoids
  • Use of prescription medication relevant to the skin
  • Undergoing any cosmetic procedures during the study including Botox, laser or chemical peel treatments
  • Deep-set of wrinkles
  • Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (for example retinoids)
  • Is pregnant or nursing, or attempting a pregnancy
  • Used retinoids before with an adverse reaction
  • Has a self-identified sensitive skin type
  • Has any learning and/or cognitive difficulties that prevent him/her reading and understanding questionnaires and surveys (e.g. dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Officials

  • Susanne Mitschke, MSc

    Citruslabs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Split face intervention
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 9, 2021

Study Start

July 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)