Placebo-Controlled Study Assessing the Use of a Novel Exfoliative Serum With A Chemical Peel to Improve Photodamage in Adults

NCT05908825 | Completed DMC

• 1 other identifier: CATALYST-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a split-face, double-blind, placebo-controlled study assessing the use of a novel exfoliative serum with a chemical peel to improve photodamage in healthy female subjects between the ages of 30 and 65 years, inclusive, with Fitzpatrick skin types I-VI.

Conditions

Photodamaged Skin

Outcome Measures

Primary Outcomes (2)

• Change in Product tolerability

  Product tolerability will be measured using the clinical grading of tolerance by evaluating the subjects reported local facial cutaneous tolerability including burning, stinging, and itching. Each scale will be measured with the following parameters, 0 = none (best possible outcome), 1 = mild, 2 = moderate, and 3 = severe (worst possible outcome). A decrease in scores or lack of significant increase indicates tolerability of the study treatment. The null hypothesis is that the mean change from baseline is zero.

  Change from Baseline at Day 42

• Change in Product efficacy

  Live Clinical Investigator grading of facial fine lines efficacy grading by using the modified Griffith's Photonumeric scale. The grading scale includes fine lines, crepiness, firmness, elasticity, smoothness, pore size, clarity, pigmentation, dark spot intensity, and skin tone evenness. The parameters for the scale are as follows, 0 = none (best possible outcome), 1 to 3 = mild, 4 to 6 = moderate, and 7 to 9 = severe (worst possible outcome). A decrease in scores indicates an improvement in study treatment efficacy. The null hypothesis is that the mean change from baseline is zero.

  Change from Baseline at Day 42

Study Arms (2)

20 day application of study product A and B

OTHER

Subjects will be given study drug and instructed to topically apply to the treatment area, Study Product A or Study Product B, placebo serum or novel exfoliative serum, to the respectively randomized half of the face, once daily for 20 consecutive days.

Drug: Vitamin C with AHA Exfoliative Serum; Drug: Placebo serum

42 day application of study product A and B

OTHER

Subjects who the investigator decides to continue treatment at Day 21, will be given study drug and instructed to topically apply to the treatment area, Study Product A or Study Product B, placebo serum or novel exfoliative serum, to the respectively randomized half of the face, once daily for an additional 21 consecutive days.

Drug: Vitamin C with AHA Exfoliative Serum; Drug: Placebo serum

Interventions

Vitamin C with AHA Exfoliative Serum DRUG

Catalyst is a novel skincare product comprised of low concentrations of multiple hydroxy acids and will be randomly assigned as Product A or Product B to be applied to one side of the face.

Also known as: Skinceuticals C + AHA

20 day application of study product A and B; 42 day application of study product A and B

Placebo serum DRUG

Placebo serum will be randomly assigned as Product A or Product B to be applied to one side of the face.

20 day application of study product A and B; 42 day application of study product A and B

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects aged between 30 and 65 years, inclusive
• Fitzpatrick skin type I-VI
• All skin types, including sensitive skin
• Mild to moderate severity (score of 3 to 6; modified Griffiths scale) of the following attributes on the global face:
• Smoothness, tactile and visual
• Dark spot intensity
• Hyperpigmentation
• Clarity
• Radiance
• Skin tone evenness
• Firmness (visual)
• Elasticity (tactile)
• Overall healthy skin appearance
• Global fine lines
• Appearance of pores

You may not qualify if:

• Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas
• Subjects with sunburn, moderate to pronounced suntan, pronounced asymmetric skin aging, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
• Subjects currently taking certain medications which in the opinion of the Investigators may interfere with the study. This includes but not limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids \[steroid nose drops, inhalers and/or eye drops are permitted\]), and immunosuppressive drugs
• Subjects with self-reported, uncontrolled systemic disease which, in the opinion of the Investigator, may hinder either the subject's ability to perform all responsibilities of the trial or the Investigator's ability to perform assessments
• Women known to be pregnant, nursing or planning to become pregnant
• Subjects participating in other facial clinical studies
• Subjects who have routinely used an alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid (BHA) containing product within two weeks or Retin-A, Retin-A Micro, Renova, Differin, Avita, Tazorac, or Soriatane within 8 weeks of the study start or have taken Isotretinoin within one year of the study start. Subjects who have used Retinol in the last 4 weeks
• Subjects with current flaring moderate to severe inflammatory acne
• Subjects who have had ablative laser treatments, microneedling, and/or chemical peels or dermabrasion within the last six months
• Subjects who have had botulinum type-A toxin (e.g. Botox®, Dysport® or Xeomin ®) within the last 3 months
• Subjects who have had dermal filler injections within the last 12 months
• Subjects who have had non-ablative laser treatments or IPL within the last 3 months
• Subjects with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
• Subjects currently using topically applied prescription medications on the face

Sponsors & Collaborators

• Austin Institute for Clinical Research: lead
• SkinCeuticals: collaborator

Study Sites (1)

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Interventions

Ascorbic Acid; acetohydroxamic acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Edward Lain, MD, MBA

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 18, 2023
• Study Start: June 22, 2023
• Primary Completion: November 16, 2023
• Study Completion: January 26, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (1)