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The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging

Primary Purpose

Photoaging

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
70% glycolic acid
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photoaging focused on measuring Photoaging, 70% glycolic acid peel

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Photoaging Grade 2-4 (face) Skin type I - IV

Exclusion Criteria:

  • Pregnancy, breast feeding Active dermatitis on the face, rosacea, allergic rhinitis, herpes Known hypersensitivity Previous Keloids Laser ablative procedures within the last one month Chemical Peels in the last 6 months Used oral retinoids in the last 6 months Used topical retinoids in the past one week Used Scrub, Alpha Hydroxy Acid, skin irritant for the past 24h Presence of facial warts, fungal infections Photoallergies Prior poor reaction to a chemical peel Radiotherapy Skin type V and VI

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Single arm of 10 patients - efficacy and safety assessed pre and post peel

Outcomes

Primary Outcome Measures

Assessment of Parameters for Photoaging
i. Physician VAS scale - Score 1 -10. ii.Fine peri-orbital wrinkles iii.Course peri-orbital wrinkles; iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma vii.Solar lentigines viii.Solar keratoses ix.Guttate hypomelanosis x.Poikiloderma The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement.
Safety Assessment
Safety profile assessment redness, swelling, oozing, hyperpigmentation, scarring each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe

Secondary Outcome Measures

Full Information

First Posted
April 28, 2014
Last Updated
April 28, 2014
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02126644
Brief Title
The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging
Official Title
Phase 2 Study of the Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Our study involves the evaluation of a high potency peel in its efficacy for skin rejuvenation in the treatment of photoaging. This chemical peel regime is a high potency peel 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. AIM We aim to qualitatively evaluate its efficacy and safety profile. Our hypothesis is that a single peel of 70% glycolic acid combined with vitamin C will result in improvement of the features of photoaging with few side effects.
Detailed Description
Assessment of photoaging to compare using photography A and E - for static analysis. For each element from ii to xi, a rating of nil (0), mild (l), moderate (2), and severe (3) for each category was made by the same evaluating physician. i. Physician VAS scale - assessment of wrinkles prepeel, post peel (Score 1 -10). ii.Fine peri-orbital wrinkles (less than 1 mm in width or depth) (FPW); iii.Course peri-orbital wrinkles (greater than 1 mm in width and depth) (CPW); iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma defined as blotchy, brown, epidermal macules with indistinct margins; vii.Solar lentigines defined as dark brown macules with distinct margins measuring from 3 to 10 mm; viii.Solar keratoses defined as diffuse erythema with keratotic adherent scaling; ix.Guttate hypomelanosis defined as localized macules of absent melanin measuring from 3 to 10 mm in diameter; x.Poikiloderma defined as a symmetrical reddish-brown pigmentation of the neck, typically sparing the sub-mental area; The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement. Safety profile assessment redness, swelling, oozing, hyperpigmentation, scarring each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe this will serve as a safety assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging
Keywords
Photoaging, 70% glycolic acid peel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Single arm of 10 patients - efficacy and safety assessed pre and post peel
Intervention Type
Drug
Intervention Name(s)
70% glycolic acid
Primary Outcome Measure Information:
Title
Assessment of Parameters for Photoaging
Description
i. Physician VAS scale - Score 1 -10. ii.Fine peri-orbital wrinkles iii.Course peri-orbital wrinkles; iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma vii.Solar lentigines viii.Solar keratoses ix.Guttate hypomelanosis x.Poikiloderma The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement.
Time Frame
3 months
Title
Safety Assessment
Description
Safety profile assessment redness, swelling, oozing, hyperpigmentation, scarring each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Photoaging Grade 2-4 (face) Skin type I - IV Exclusion Criteria: Pregnancy, breast feeding Active dermatitis on the face, rosacea, allergic rhinitis, herpes Known hypersensitivity Previous Keloids Laser ablative procedures within the last one month Chemical Peels in the last 6 months Used oral retinoids in the last 6 months Used topical retinoids in the past one week Used Scrub, Alpha Hydroxy Acid, skin irritant for the past 24h Presence of facial warts, fungal infections Photoallergies Prior poor reaction to a chemical peel Radiotherapy Skin type V and VI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam SY Yang, Dr
Phone
85333992
Email
samsyyang@gmail.com
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Yang, Dr
Phone
85333992
Email
samsyyang@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging

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