Acne ScarsPhase 2NCT02126657
The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
A Phase 2 study testing 70% glycolic acid in people with Acne Scars, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. This chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars
- What is being tested?
- 70% glycolic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- May 2014to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Atrophic scars
- Skin type I to IV
Who cannot join
- Pregnancy, breastfeeding
- Active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex
- Known hypersensitivity
- Previous keloids
- Laser ablative procedures within the last month
- Chemical peels within the last 6 months
Show all 15Show fewer
- Used oral retinoids in the past 6 months
- Used topical retinoids in the past one week
- Used scrub, AHA, skin irritant for the past 24h
- Presence of facial warts or fungal infections
- Photoallergies
- Prior poor reaction to a chemical peel
- Radiotherapy
- Skin type V and VI
- Patients with predominantly ice pick and boxcar scars
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Hospital
Singapore, Singapore, 119074
Sam Yang, Dr, 85333992, samsyyang@gmail.com
About this study
Official title: Phase 2 Study of the The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
Our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. This chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a single application. The study design is based on a single group that compares pre- vs post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited. Potential benefits include improvement of post acne scars with a short downtime and risks include post peel hyper pigmentation and scarring. We believe that this treatment will be highly beneficial to patients with post acne scarring.
This chemical peel regime has good efficacy and safety profile for the treatment of acne scars.
Read the detailed description
Primary endpoints:
- ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars. Two blinded evaluators compare and rate the photograph using ECCA score.
- Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar
Secondary endpoints:
- Postacne hyperpigmentation index (PAHPI) -Each of these 3 variables --size, intensity, and number of lesions is weighted and the summation of the weighted variables gives the total PAHPI score, ranging 6 to 22.
- Safety Assessment (This is an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring vi. Assessment based on patient and doctor global assessment (global assessment from 1 - 10)
- Conditions
- Acne Scars
- Being tested
- 70% glycolic acid
- Keywords
- Acne scars, 70% Glycolic acid peel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% glycolic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single arm study - pre and post peel assessment Receives: Drug: 70% glycolic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Assessment
- ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars
- V-shaped atrophic scars with diameter <2 mm: 15
- U-shaped atrophic scars with a diameter of 2-4 mm: 20
- M-shaped atrophic scars with diameter >4 mm: 25
- Superficial elastolysis: 30
- Hypertrophic scars with a <2-year duration: 40
- Hypertrophic scars of >2-year duration: 50 A semi-quantitative scoring of number of each scar will be performed
- No scars: 0
- Less than five scars: 1
- Between five and 20 scars: 2
- More than 20 scars: 3
- Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar
Secondary endpoints
- Postacne hyperpigmentation index (PAHPI)
Measured: 3 months
Safety Assessment
) Safety Assessment (This is also an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126657
- Sponsor's protocol ID
- 2013/01230
- Status last verified
- Apr 2014
- First submitted
- 28 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
- ClinicalTrials.gov ID
- NCT02126657
- Acronym / sponsor ID
- 2013/01230
- Conditions
- Acne Scars
- Keywords
- Acne scars, 70% Glycolic acid peel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. This chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a single application. The study design is based on a single group that compares pre- vs post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited. Potential benefits include improvement of post acne scars with a short downtime and risks include post peel hyper pigmentation and scarring. We believe that this treatment will be highly beneficial to patients with post acne scarring.
This chemical peel regime has good efficacy and safety profile for the treatment of acne scars.
Detailed description
Primary endpoints:
- ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars. Two blinded evaluators compare and rate the photograph using ECCA score.
- Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar
Secondary endpoints:
- Postacne hyperpigmentation index (PAHPI) -Each of these 3 variables --size, intensity, and number of lesions is weighted and the summation of the weighted variables gives the total PAHPI score, ranging 6 to 22.
- Safety Assessment (This is an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring vi. Assessment based on patient and doctor global assessment (global assessment from 1 - 10)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: 70% glycolic acidSingle arm study - pre and post peel assessment |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Atrophic scars
- Skin type I to IV
Key exclusion criteria (15 listed)
- Pregnancy, breastfeeding
- Active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex
- Known hypersensitivity
- Previous keloids
- Laser ablative procedures within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 70% glycolic acid | Drug | Single Arm |
Primary outcome
Efficacy Assessment
Time frame: 3 months
1. ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars * V-shaped atrophic scars with diameter <2 mm: 15 * U-shaped atrophic scars with a diameter of 2-4 mm: 20 * M-shaped atrophic scars with diameter >4 mm: 25 * Superficial elastolysis: 30 * Hypertrophic scars with a <2-year duration: 40 * Hypertrophic scars of >2-year duration: 50 A semi-quantitative scoring of number of each scar will be performed * No scars: 0 * Less than five scars: 1 * Between five and 20 scars: 2 * More than 20 scars: 3 2. Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar Secondary endpoints 1) Postacne hyperpigmentation index (PAHPI)
Safety Assessment
Time frame: 3 months
) Safety Assessment (This is also an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 70% glycolic acid in people with Acne Scars, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam SY Yang, Dr (85333992, samsyyang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Assessment (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.