Trial Assessing the Impact on Facial Skin Quality, Hydration, and Skin Barrier of Three (3) Hydrafacial Treatments in Adults of All Skin Types.

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase IV, unblinded, open-label study assessing the impact on skin quality, hydration, and barrier of three (3) Hydrafacial treatments in healthy adults of Fitzpatrick Skin Types I & II, III, IV, V & VI, 30 to 55 years of age. Efficacy and subject satisfaction will be assessed, before and after three (3) HF treatments, in 6 patient cohorts, each cohort defined by FST I-VI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Austin Institute for Clinical Research
• Collaborator: The HydraFacial Company

Criteria

Inclusion Criteria:

1. Healthy males and females of Fitzpatrick skin types I-VI 30-55 years of age.

2. No known medical conditions that in the investigator's opinion may interfere with study participation.

3. Agrees to abstain from starting a new skincare product for the duration of trial participation.

4. Willingness to cooperate and participate by following study requirements.

5. Individuals must sign an informed consent and photography consent.

Exclusion Criteria:

1. History of any cancer excluding fully treated basal cell carcinoma or squamous cell carcinoma in situ in the treatment area.

2. Presence of untreated precancerous lesions in the treatment area.

3. Presence of sunburn, moderate to pronounced suntan, uneven skin tone, tattoos, scars or other disfiguration in the treatment area.

4. Any cutaneous condition that may affect study adherence or ability to assess endpoints, as determined by the investigator, to include, but not limited to, uncontrolled psoriasis, atopic dermatitis, severe photodamage, and uncontrolled acne.

5. Subject is pregnant, nursing, or planning to become pregnant.

6. Significant past medical history of hepatic, hypertensive, renal, cardiac, pulmonary, digestive, hematological, neurological, or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.

7. Currently participating in another clinical trial.

8. History of Photo Epilepsy.