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

Completed · Not applicable · Has a placebo group

Conditions studied: Photodamaged Skin

In brief

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.

Key facts

Study ID

NCT05908825

Run by

Austin Institute for Clinical Research

People needed

34

Starts

2023-06-22

Expected to finish

2024-01-26

Last updated by the study team

2024-07-19

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: accepted.

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
• No known medical conditions that, in the Investigator's opinion may interfere with study participation
• Willingness to cooperate and participate by following study requirements
• Individuals must sign an informed consent and a photography consent

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

Where it is running

• Austin Institute for Clinical Research, Inc. — Pflugerville, Texas, United States

Full record on ClinicalTrials.gov

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