Assessment of the Cosmetic Benefit of a Skin Cream in Healthy Females With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a Glycolic Acid Facial Peel Procedure

A Randomized, Evaluator-blind, Single-center and Two-arm Clinical Study Designed to Evaluate the Local Tolerance and Cosmetic Efficacy of a Topical Skin Care Formulation in Healthy Female Subjects With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a 70% Glycolic Acid Facial Peel Procedure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03197883

Enrollment

123

Registered

2017-06-23

Start date

2017-07-17

Completion date

2017-10-31

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Care

Brief summary

To evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy female participants with mild to advanced photo-damaged facial skin who have undergone a 70% Glycolic Acid facial peel procedure.

Detailed description

This will be a randomized, evaluator-blind, single-center and two-arm clinical study designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy female participants with mild to advanced photo-damaged facial skin who have undergone a 70% Glycolic Acid facial peel procedure.

Interventions

OTHERTest Product

Restoring lipid balm

OTHERCleanser

Moisturizing facial cleanser

OTHERSunscreen

SPF (Sun Protection Factor) 50 sunscreen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Females aged between 30 and 60 years inclusive. * Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination. * Willingness to actively participate in the study and to attend all scheduled visits. * Skin Type: Fitzpatrick phototype II-IV and participants with Glogau photoaging type II-III * Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.

Exclusion criteria

* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * Women who are breast-feeding. * a) Active skin disease or open wound in the test area, b) Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 24 months, c)Medical history of dysplastic nevi or melanoma, d) Preexisting inflammatory dermatoses such as psoriasis, atopic dermatitis, e) Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could, in the opinion of the investigator, influence the investigation, f) Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to screening and/or throughout the entire course of the study, g) Systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to screening. h)Systemic use of any photosensitizing medication 2 weeks prior to screening, i) Intense sun exposure, UV-treatments or tanning salon visit within two weeks prior to screening, j) One of the following illnesses that might require regular systemic medication; Insulin-dependent diabetes, cancer, k) One of the following illnesses if not medicated: Asthma, hypertension, l) Medical history of abnormal response to sunlight, m) Participant's with a history of mental illness, n) Ocular surgery within the last 12 months. o) Ocular trauma, infection or inflammation within the last 3 months, p) Active blepharitis, conjunctivitis, uveitis, q) Any ocular pathology requiring topical ocular treatment within the last 1 month, r) Ocular laser within the last 3 months, s) Aesthetic, cosmetic or dermatological treatment in the treatment area (face), including the use of skin tone lightning products, within the last 3 months, t) Use of facial scrubs, depilatory creams, waxing and/or bleaching within the last 2 weeks prior to screening, u) Microdermabrasion and/or laser hair removal within the last 4 weeks prior to screening, v) Medical history of Herpes Simplex (Cold Sores). * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients and documented allergies to cosmetic products or study ingredients. * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study. * Recent history (within the last 5 years) of alcohol or other substance abuse. * An employee of the sponsor or the study site or members of their immediate family. * Required to work outside during daylight hours over the duration of the study and required or otherwise intending to spend prolonged periods of time outside during daylight hours over the duration of the study (e.g. holiday, sunbathing, and gardening). * A score of Severe for any Dermatologist or Participant's Self-Assessed endpoint at any time for the study material sensitivity test.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores	14 days after completion of the facial peel procedure	The dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use.

Secondary

Measure	Time frame	Description
Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness	14 days after completion of the facial peel procedure	The signs/symptoms of participants were scored on a scale of 0 to 3 as below: Erythema: Score from 0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red in color. Dryness: Score from 0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling and peeling of skin over all areas of the test site. Desquamation score from 0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin and easily removable. Edema score from 0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe-Marked/pronounced edema present.
Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness	14 days after completion of the facial peel procedure	The assessments of Pain, Stinging/ Burning, Itching, Tightness, Redness and Dryness were conducted by participants reflective of their skin condition at the 5 x 5 cm square area on the volar surface of the forearm at the time of evaluation. Participants were scored as per signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3, where 0= none; no sign or symptoms, 1= mild; barely perceptible, 2= moderate; definite signs and symptoms, and 3= severe- marked or pronounced signs or symptoms. This outcome measure is the sum of participant scores, so a total score, i.e. the range is 0-15, with higher scores indicating increased signs or symptoms of irritation.
Change From Baseline in Participant Self-assessment Scores for Redness	14 days after completion of the facial peel procedure	The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for redness. Participants were score on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.
Change From Baseline in Participant Self-assessment Scores for Pain	14 days after completion of the facial peel procedure	The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for pain. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.
Change From Baseline in Participant Self-assessment Scores for Itching	14 days after completion of the facial peel procedure	The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for itching. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.
Change From Baseline in Total Score of Dermatologist Assessments	14 days after completion of the facial peel procedure	The assessments of Erythema, Dryness, Desquamation and Edema were conducted by a dermatologist on the participant's skin condition at the 5 x 5 cm square area on the volar surface of forearm. The signs were scored on a scale. Erythema on 0-3 where, 0=none-no redness, 1=mild-slight redness, 2=moderate-definite redness, 3=severe-marked redness. Dryness on 0-3 where, 0=none-no dryness, 1=mild-barely perceptible, fine scales to limited areas of test site, 2=moderate-fine scales generalized to all areas of test site, 3=severe-scaling and peeling of skin over all areas of test site. Desquamation on 0-3 where, 0=none-no sign of peeling, 1=mild-barely perceptible scaling, 2=moderate-minimal scaling, 3=severe-moderate scaling. Edema on 0-3 where, 0=none-no edema, 1=mild-barely perceptible edema, 2=moderate-definite edema, 3=severe-pronounced edema. The measure is sum of participant scores, so a total score scale ranges from 0-12, with higher scores indicating increased signs of irritation.
Change From Baseline in Participant Self-assessment Scores for Tightness	14 days after completion of the facial peel procedure	The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for tightness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.
Change From Baseline in Participant Self-assessment Scores for Dryness	14 days after completion of the facial peel procedure	The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for dryness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.
Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter	14 days after completion of the facial peel procedure	Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter. Measurements were taken in triplicates on the left cheek (below the cheekbone between the nose and ear). TEWL measurements were taken with the participant lying horizontally, on their back, so that the chimney of the Tewameter probe is aligned vertically. An increase in TEWL values shows damage to the skin barrier function.
Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer	14 days after completion of the facial peel procedure	Measurement of stratum corneum hydration was performed by the electrical capacitance method with a Corneometer. Corneometer measurements were taken in triplicates at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.
Global Self-assessment of Participants	14 days after completion of the facial peel procedure	Participants has rated the level of satisfaction with the post-procedure skin care regimen to which they were randomized on a scale of 0 to 3 as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied). Lower scores indicate better results.
Change From Baseline in Participant Self-assessment Scores for Stinging/Burning	14 days after completion of the facial peel procedure	The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for stinging/burning. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.

Countries

Brazil

Participant flow

Recruitment details

All the participants were recruited from one center in Brazil.

Pre-assignment details

A total of 163 participants were screened, out of which 31 did not meet study criteria, 7 had adverse events (AEs), 1 participant was lost to follow-up, 1 withdrew his consent and 23 participants were not randomized in the study due to other reasons (not specified).

Participants by arm

Arm	Count
Test Product Participants dispensed a pea-sized quantity of test product (approximately 0.6-1 g) onto the fingertips and applied twice daily (morning and evening) to the full face after cleansing. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen; approximately 0.6 to 1.0 g) on the full face in the morning (after application of test product) and at lunchtime.	50
No Treatment Participants dispensed approximately 0.6 to 1.0 g of cleanser into the hands, worked into a lather, massaged onto the full face (wet skin), and rinsed with water, twice a day (morning and evening). After cleansing, participants applied a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.	46
Total	96

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Other (Not Specified)	0	5
Overall Study	Protocol Violation	1	0

Baseline characteristics

Characteristic	Total	No Treatment	Test Product
Age, Continuous	45.5 Years STANDARD_DEVIATION 7.9	45.1 Years STANDARD_DEVIATION 8.35	45.9 Years STANDARD_DEVIATION 7.54
Fitzpatrick Skin Type I- Always Burns, Never Tans	0 Participants	0 Participants	0 Participants
Fitzpatrick Skin Type III- Sometimes mild Burn, Tans uniformly	65 Participants	31 Participants	34 Participants
Fitzpatrick Skin Type II- Usually Burns, Tans Minimally	31 Participants	15 Participants	16 Participants
Fitzpatrick Skin Type IV- Burns Minimally, Always Tans well	0 Participants	0 Participants	0 Participants
Fitzpatrick Skin Type VI- Never Burns, Never Tans	0 Participants	0 Participants	0 Participants
Fitzpatrick Skin Type V- Very rarely Burns, Tans very easily	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	7 Participants	5 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants	5 Participants	3 Participants
Race (NIH/OMB) White	81 Participants	36 Participants	45 Participants
Sex: Female, Male Female	96 Participants	46 Participants	50 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 50	0 / 46
other Total, other adverse events	5 / 50	0 / 46
serious Total, serious adverse events	0 / 50	0 / 46

Outcome results

Primary

Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores

The dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use.