An interventional study of Balancing gel cream in Skin Microboime and Acne, sponsored by Integrative Skin Science and Research. Recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Integrative Skin Science and Research · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.
Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Integrative Skin Science and Research is the lead sponsor of 34 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Product will be used twice daily in the morning and in the evening for 6 weeks. 1-2 pumps (dime size) of product will be applied on the face. In addition to the study product, a Cetaphil cleanser will be used as well. Cleanser will be applied twice daily in the morning and in the evening for 6 weeks. Cleanser will be used on wet face and gently pat dry.
Other: Balancing gel cream
Skin balancing gel cream will be applied onto clean skin morning and night
C. acnes relative abundance
Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
Time frame: 6 weeks
Functional gene based predictive analysis of skin inflammation related genes
Functional gene analysis for skin inflammation related genes from whole genome sequencing of facial skin microbiome
Time frame: 6 weeks
Sebum excretion rate
Measure of skin sebum via sebumeter
Time frame: 6 weeks
Tolerability Assessment Questionnaire
A 6 question survey based on the self-assessment about the tolerability of the topical skin product such as itching, burning, and stinging. The scale ranges from 0-3 with 0 being the best outcome possible and with 3 being the worst. "0" as none, "1" as mild, "2" as moderate, or "3" as severe.
Time frame: 6 weeks
Total lesion count
Safety endpoint to count inflammatory and non-inflammatory lesions to ensure that there is not a flare in the acne
Time frame: 6 weeks
Plan to share: No
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Integrative Skin Science and Research